A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

A Multicenter, 12 Week, Double-blind, Placebo-controlled, Randomized Withdrawal Study To Determine The Efficacy And Safety Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-release Capsules In Subjects With Moderate To Severe Chronic Low Back Pain

The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Chronic Pain; Analgesia
• Intervention / Treatment: Drug: ALO-02; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 410
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research, Inc.
  • Arizona
    • Goodyear, Arizona, United States, 85395
      • Dedicated Clinical Research
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center
    • Phoenix, Arizona, United States, 85027
      • Premier Research Group Limited
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
    • Carmichael, California, United States, 95608
      • Med Center
    • Fair Oaks, California, United States, 95628
      • Med Investigations, Inc.
    • Fresno, California, United States, 93710
      • Neuro-Pain Medical Center
    • Laguna Hills, California, United States, 92637
      • Pacific Coast Pain Management Center
    • Long Beach, California, United States, 90807
      • Long Beach Center For Clinical Research
    • Long Beach, California, United States, 90806
      • Long Beach Center for Clinical Research - previous addresse
    • North Hollywood, California, United States, 91606
      • Providence Clinical Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80904
      • Clinicos, LLC
    • Colorado Springs, Colorado, United States, 80907
      • Lynn Institute of the Rockies Medical Centre
  • Florida
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research, LLC
    • Ormond Beach, Florida, United States, 32174
      • Ormond Medical Arts Pharmaceutical Research Center
    • Plantation, Florida, United States, 33317
      • Gold Coast Research, LLC
    • Plantation, Florida, United States, 33317
      • The Office of Martin E. Hale, MD, PA
    • Port Orange, Florida, United States, 32129
      • Accord Clinical Research, LLC- Duplicate 2
    • Port Orange, Florida, United States, 32129
      • Accord Clinical Research, LLC- Duplicate
    • Tampa, Florida, United States, 33603
      • Clinical Research of West Florida
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Georgia Institute for Clinical Research, LLC
    • Marietta, Georgia, United States, 30060
      • Drug Studies America
  • Indiana
    • Evansville, Indiana, United States, 47714
      • MediSphere Medical Research Center, LLC
  • Maryland
    • Hollywood, Maryland, United States, 20636
      • Mid-Atlantic Medical Research - Research Department
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Clinical Pharmacology Study Group
  • Missouri
    • St. Louis, Missouri, United States, 63141
      • Mercy Health Research
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Heartland Clinical Research, Inc.
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Office of Stephen H. Miller, M.D.
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
  • New York
    • Hartsdale, New York, United States, 10530
      • Drug Trials America
    • New Windsor, New York, United States, 12553
      • Mid Hudson Medical Research, PLLC
    • New York, New York, United States, 10022
      • Research Across America
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates, LLC
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Community Research
    • Columbus, Ohio, United States, 43213
      • Columbus Clinical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73119
      • Hillcrest Clinical Research
    • Oklahoma City, Oklahoma, United States, 73119
      • Associated Orthopedics
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Allegheny Pain Management, PC
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Pain Research of Charleston
    • Columbia, South Carolina, United States, 29204
      • TLM Medical Services
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas, LP
    • Dallas, Texas, United States, 75230
      • KRK Medical Research
    • San Antonio, Texas, United States, 78209
      • Quality Research Inc.
    • San Antonio, Texas, United States, 78229
      • Lee Medical Associates
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Research, P.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Moderate-to-severe chronic low back pain present for at least 3 months.
• Require a continuous around-the-clock opioid analgesic for an extended period of time.
• Refrain from taking other opioid and non-opioid medications during the study.

Exclusion Criteria:

• Active or within a past 2 years a history of lumbosacral radiculopathy or chronic low back pain due to other underlying disorders such as spinal stenosis with neurologic impairment, cancer, infection, or post-surgical intervention.
• Documented diagnosis of ongoing pain due to other chronic pain conditions which may interfere with assessment of chronic low back pain.
• Active or ongoing or history of alcohol or drug abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; oral placebo, divided into symmetric doses and administered twice daily
Experimental: ALO-02	Drug: ALO-02; 20 to 160mg total daily dose of oxycodone, divided into symmetric doses and administered twice daily; Other Names: oxycodone HCl and naltrexone HCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12)	Weekly average diary NRS-Pain scores were derived from the daily NRS-pain scale and calculated as the mean of the last 7 days. NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.	Weeks 11 and 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit).	The RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain. An individual participant's score can vary from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher score indicating greater disability.	Week 12
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit).	Measure represents the score at Randomization Baseline / score at Week 12 (or Early Termination) in PGA, a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor).	Randomization Baseline, Week 12
Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction of Greater or Equal to (≥) 20%	Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 equals (=) no pain to 10 = worst possible pain. Higher scores indicate greater pain.	Weeks 11 and 12
Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥30%	Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.	Weeks 11 and 12
Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥40%	Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.	Weeks 11 and 12
Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥50%	Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.	Weeks 11 and 12
Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index	BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.	Screening, Week 4, 5, or 6
Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index	BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.	Screening, Randomization Baseline
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain	BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.	Weeks 2, 4, 8, and 12
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain	BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.	Weeks 2, 4, 8, and 12
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain	BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.	Weeks 2, 4, 8, and 12
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now	BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.	Weeks 2, 4, 8, and 12
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index	Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity.	Weeks 2, 4, 8, and 12
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index	Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.	Weeks 2, 4, 8, and 12
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain	BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.	Weeks 2, 4, 8 and 12
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain	BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.	Weeks 2, 4, 8, and 12
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain	BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.	Weeks 2, 4, 8, and 12
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now	BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.	Weeks 2, 4, 8, and 12
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index	Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity.	Weeks 2, 4, 8, and 12
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index	Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.	Weeks 2, 4, 8, and 12
Area Under the Curve (AUC) of eDiary NRS-Pain Scores From Randomization Baseline to Final 2 Weeks of the Double-Blind Treatment Period (Weeks 11 and 12)	NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). AUC was calculated using daily change from Baseline scores from Baseline until the last dose date in the Double-Blind Treatment Period. AUC was calculated for each participant using the linear trapezoidal method. Higher scores indicate greater pain.	Randomization Baseline, Weeks 11 and 12
Average Daily Use of Rescue Acetaminophen (Milligrams Per Day [mg/Day]) During the Double-Blind Treatment Period	The amount of acetaminophen administered for each treatment during the Double-Blind Treatment Period. Average daily use calculated as: total dose of rescue medication during Double-Blind Period divided by the number of days in Double-Blind Period.	Daily from Day 1 of the Double-Blind Period through Week 12
Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment	The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times100.	Screening, Week 4, 5 or 6
Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment	The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period minus (-) Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. An event was defined as a participant with 20, 30, 40, or 50% analgesic response from Screening. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the [date of event or last diary pain score - date of first dose in Titration Period +1].	Screening, Week 4, 5, or 6
Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline	The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100.	Screening, Randomization Baseline (up to 6 weeks)
Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline	The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the [date of event or last diary pain score - date of first dose in Titration Period +1].	Screening, Randomization Baseline (up to 6 weeks)
Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period	The percentage of lost analgesic response is defined as: (rolling 7-day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the [date of event or last diary pain score - date of first dose in Double-Blind Treatment +1].	Randomization Baseline, up to Week 12
Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period	The percentage of lost analgesic response was defined as: (rolling seven day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the [date of event or last diary pain score - date of first dose in Double-Blind Treatment +1].	Randomization Baseline, up to Week 12
Percentage of Participants Discontinuing Treatment for Investigator-Reported Lack of Efficacy	If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason.	Week 1 up to Week 12
Median Time to Treatment Discontinuation for Investigator-Reported Lack of Efficacy During the Double-Blind Treatment Period	If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason. The survival duration begins on the date of first dose in the Double-Blind period and is calculated as the [date of event or discontinuation - date of first dose in Double-Blind Period +1].	Week 1 up to Week 12
Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period	The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.	Screening, Weeks 1, 2, 3, 4, 5, and 6
COWS Total Score During the Double-Blind Treatment Period	The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.	Randomization Baseline, Weeks 1, 2, 4, 8, and 12
COWS Total Score During the Post-Treatment Period	The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.	Follow-Up (FU) Weeks 1 and 2
Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category	The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.	Screening, Weeks 1, 2, 3, 4, 5, 6 (or Early Termination)
Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category	The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.	Randomization Baseline, Weeks 1, 2, 4, 8, 12 (or Early Termination)
Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category	The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.	Follow-Up Weeks 1 and 2
Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period	The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.	Screening, Weeks 1, 2, 3, 4, 5, and 6
SOWS Total Score During the Double-Blind Treatment Period	The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.	Randomization Baseline, Weeks 1, 2, 4, 8, and 12
SOWS Total Score During the Post-Treatment Period	The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.	Follow-Up Weeks 1 and 2
Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants	RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher scores indicating greater disability.	Screening, Week 6 (or Early Termination)
Change From Screening Period to Randomization Baseline in RMDQ Total Score	RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.	Screening, Randomization Baseline
Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score	RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.	Screening, Weeks 2, 4, 8, and 12
Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score	RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.	Randomization Baseline, Weeks 2, 4, and 8
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor	Represents the score at Screening / score at Randomization Baseline in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.	Screening, Randomization Baseline
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor	Represents the score at Screening / score at to end of the titration period in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.	Screening, Randomization Baseline, or Early Termination
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor	Represents the score at Randomization Baseline / score at Week 4 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.	Randomization Baseline, Week 4
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor	Represents the score at Randomization Baseline / score at Week 8 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.	Randomization Baseline, Week 8
Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants	Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied.	End of Open-Label Titration Period (Week 4, 5, or 6 or Early Termination)
Satisfaction With Treatment at Randomization Baseline	Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied.	Randomization Baseline
Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period	Participants used an electronic tablet at the center to rate their overall treatment satisfaction with study drug during study participation using a 5-point categorical scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied).	Week 12 or Early Termination
Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score	SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher scores indicates a better health state.	Screening, Week 6 (or Early Termination)
Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score	SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.	Screening, Randomization Baseline
Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey	SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.	Randomization Baseline, Week 12
Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey	SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.	Screening, Week 12
Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index	The EQ 5D Health Questionnaire is a self completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.	Screening, Week 6 (or Early Termination)
Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS	The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.	Screening, Week 6 (or Early Termination)
Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index	Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health	Screening, Randomization Baseline
Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS	The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.	Screening, Randomization Baseline
Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index	Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health	Randomization Baseline, Week 12
Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using the EQ-5D VAS	The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.	Randomization Baseline, Week 12
Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index	Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.	Screening, Week 12
Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D VAS	The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.	Screening, Week 12
Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment /absenteeism+presenteeism); and activity impairment.; work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4).; impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5).; overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism).; activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.	Screening, Week 6 (or Early Termination)
Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.; work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4).; impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5).; overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism).; activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.	Screening, Randomization Baseline
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.	Randomization Baseline, Weeks 4, 8, and 12
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.	Randomization Baseline, Weeks 4, 8, and 12
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.	Randomization Baseline, Weeks 4, 8, and 12
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.	Randomization Baseline, Weeks 4, 8, and 12
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.	Screening, Weeks 4, 8, and 12
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.	Screening, Weeks 4, 8, and 12
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.	Screening, Weeks 4, 8, and 12
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.	Screening, Weeks 4, 8, and 12
Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire	Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?	Screening, Week 6 (or Early Termination)
Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire	Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?	Screening, Randomization Baseline
Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain	Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.	Screening, Randomization Baseline
Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks	Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain	Screening, Randomization Baseline
Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital	Question 3b: nights stayed in the hospital, if answer to Q3a was yes.	Screening, Randomization Baseline
Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain	Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.	Screening, Week 6 (or Early Termination)
Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks	Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain	Screening, Week 6 (or Early Termination)
Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital	Question 3b: nights stayed in the hospital, if answer to Q3a was yes.	Screening, Week 6 (or Early Termination)
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire	Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?	Randomization Baseline, Weeks 4, 8, and 12 (or Early Termination)
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain	Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain	Randomization Baseline, Weeks 4, 8, and 12
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments	Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain.	Randomization Baseline, Weeks 4, 8, and 12
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital	Question 3b: nights stayed in the hospital	Randomization Baseline, Weeks 4, 8, and 12
Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire	Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?	Screening, Weeks 4, 8, and 12
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain	Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain	Screening, Weeks 4, 8, and 12
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain	Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain	Screening, Weeks 4, 8, and 12
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain	Question 3b: nights stayed in the hospital	Screening, Weeks 4, 8, and 12
Mean Oxycodone Average Daily Dose During the Open-Label Titration Period		Open-Label Period
Mean Oxycodone Duration of Titration During the Open-Label Titration Period		Open-Label Period
Median Oxycodone Average Daily Dose During the Open-Label Titration Period		Open-Label Period
Median Oxycodone Duration of Titration During the Open-Label Titration Period		Open-Label Period
Mean Oxycodone Average Daily Dose During the Double-Blind Treatment Period		Double-Blind Period
Mean Oxycodone Duration of Treatment During the Double-Blind Treatment Period		Double-Blind Period
Median Oxycodone Average Daily Dose During the Double-Blind Treatment Period		Double-Blind Period
Median Oxycodone Duration of Treatment During the Double-Blind Treatment Period		Double-Blind Period
Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period	Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone.	Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline
Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period	Cobs of naltrexone and 6-β-naltrexol	Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline
Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period	Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone	Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12
Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period	Observed steady-state plasma concentration (Cobs) of naltrexone and 6-β-naltrexol	Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Gimbel JS, Rauck RL, Bass A, Wilson J, Pixton G, Malhotra B, Wilson G, Wolfram G. Effects of naltrexone exposure observed in two phase three studies with ALO-02, an extended-release oxycodone surrounding sequestered naltrexone. J Opioid Manag. 2019 Sep/Oct;15(5):417-427. doi: 10.5055/jom.2019.0530.
• Wilson JG, Bass A, Pixton GC, Wolfram G, Rauck RL. Safety and tolerability of ALO-02 (oxycodone hydrochloride and sequestered naltrexone hydrochloride) extended-release capsules in older patients: a pooled analysis of two clinical trials. Curr Med Res Opin. 2020 Jan;36(1):91-99. doi: 10.1080/03007995.2019.1661679. Epub 2019 Sep 17.
• Weil AJ, Masters ET, Barsdorf AI, Bass A, Pixton G, Wilson JG, Wolfram G. Patient-reported health-related quality of life, work productivity, and activity impairment during treatment with ALO-02 (extended-release oxycodone and sequestered naltrexone) for moderate-to-severe chronic low back pain. Health Qual Life Outcomes. 2017 Oct 17;15(1):202. doi: 10.1186/s12955-017-0749-y.
• Rauck RL, Hale ME, Bass A, Bramson C, Pixton G, Wilson JG, Setnik B, Meisner P, Sommerville KW, Malhotra BK, Wolfram G. A randomized double-blind, placebo-controlled efficacy and safety study of ALO-02 (extended-release oxycodone surrounding sequestered naltrexone) for moderate-to-severe chronic low back pain treatment. Pain. 2015 Sep;156(9):1660-1669. doi: 10.1097/j.pain.0000000000000230.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 3, 2012
• First Submitted That Met QC Criteria: April 3, 2012
• First Posted (Estimate): April 5, 2012

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: February 17, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: chronic pain; low back pain; oxycodone; naltrexone
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Alcohol Deterrents; Naltrexone; Oxycodone
• Other Study ID Numbers: B4531002; ALO-02-10-3002 (Other Identifier: Alias Study Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No