Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)

A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-Controlled, Safety, Tolerability, and Efficacy Study of Oxycodone DETERx™ Versus Placebo in Opioid-Experienced and Opioid-Naive Subjects With Moderate-to-Severe Chronic Low Back Pain

Sponsors

Lead Sponsor: Collegium Pharmaceutical, Inc.

Source Collegium Pharmaceutical, Inc.
Brief Summary

The purpose of this study is to evaluate the analgesic efficacy of Oxycodone DETERx compared with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe chronic low back pain requiring around-the-clock opioid analgesia for an extended period of time.

Overall Status Completed
Start Date August 2012
Completion Date July 2014
Primary Completion Date June 2014
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase Randomized Baseline through Week 12
Secondary Outcome
Measure Time Frame
Time-to-exit From the Study for All Causes Randomization Baseline through Week 12
Percent Reduction in Pain Intensity for Responders Screening Baseline through Week 12
Weekly Changes in Pain Intensity Randomization Baseline and weekly through Week 12
Rescue Medication Usage by Dose Randomization Baseline through Week 12
Rescue Medication Use by Dosage Randomization Baseline through Week 12
Patient Global Impression of Change (PGIC) Screening Baseline through Week 12
Changes in Quality of Life Randomization Baseline through Week 12
Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ) Randomization Baseline and Week 12
Enrollment 740
Condition
Intervention

Intervention Type: Drug

Intervention Name: Oxycodone DETERx

Description: 40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h

Arm Group Label: Oxycodone DETERx

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo, divided into 2 doses, q12h

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria:

- Male or non-pregnant female 18-75 years of age (inclusive) at the time of consent.

- Must have a clinical diagnosis of moderate-to-severe CLBP for a minimum of 6 months prior to screening.

- Must qualify for ATC opioid therapy for treatment of CLBP.

- Must be classified as non-malignant and non-neuropathic (Class 1 and 2), neuropathic (Class 3), or symptomatic for more than 6 months after low back pain surgery (Class 9) based on the Quebec Task Force Scale score.

- Female subjects of childbearing potential will use an acceptable method of birth control.

- Must be in general good health based on screening physical examination.

- Must be willing and able to comply with all study procedures and visit requirements.

Exclusion Criteria:

- Known to be refractory or intolerant to the analgesic effects of opioids or have failed previous opioid therapy.

- A medical condition that would compromise the subject's ability to swallow, absorb, metabolize, or excrete the study drug, including (but not limited to) intractable nausea and/or vomiting and/or severe gastrointestinal narrowing (pathologic or iatrogenic), bowel obstruction, ileostomy, colostomy, or is suspected of having paralytic ileus.

- A surgical procedure for back pain within 6 months prior to the Screening Visit.

- Any other chronic pain condition other than CLBP that would interfere with the assessment of CLBP (e.g., osteoarthritis, rheumatoid arthritis, post-herpetic neuralgia, pain associated with diabetic neuropathy, fibromyalgia, migraine headaches requiring opioid therapy).

- Known history of major depressive disorder that is not controlled with medication or has other conditions that produce significant cognitive or emotional disability.

- Any clinically significant unstable medical abnormality or acute or chronic disease of the cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary disease), hepatic, or renal systems.

- Known history of alcohol and/or drug abuse.

- Positive urine drug screen for illegal or non-prescribed drugs

- Known history of seizure disorder, epilepsy, convulsions, or increased intracranial pressure anytime during the subject's life except pediatric febrile seizures.

- Known history of head injury within 6 months of Screening Visit.

- Current malignancy or a history within past 2 years of malignancy, with the exception of basal cell carcinoma or cervical carcinoma in situ that have been successfully treated.

- Positive for human immunodeficiency virus (HIV) or hepatitis B surface antigen, or hepatitis C antibody

- Subject is not able or is unwilling to meet the study attendance requirements.

Other protocol specific inclusion and exclusion criteria may apply.

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Diana Meske, PhD Study Director Collegium Pharmaceutical, Inc.
Location
Facility:
| Mesa, Arizona, 85282, United States
| Phoenix, Arizona, 85050, United States
| Tucson, Arizona, 85704, United States
| Anaheim, California, 92801, United States
| Anaheim, California, 92804, United States
| Buena Park, California, 90620, United States
| Cerritos, California, 90703, United States
| Escondido, California, 92025, United States
| La Mesa, California, 91942, United States
| Napa, California, 94558, United States
| Pasadena, California, 91105, United States
| DeLand, Florida, 32720, United States
| Naples, Florida, 34108, United States
| Orlando, Florida, 32860, United States
| Plantation, Florida, 33317, United States
| West Palm Beach, Florida, 33409, United States
| Columbus, Georgia, 31904, United States
| Marietta, Georgia, 30060, United States
| Indianapolis, Indiana, 46203, United States
| Valparaiso, Indiana, 46383, United States
| Overland Park, Kansas, 66211, United States
| Brockton, Massachusetts, 02301, United States
| Natick, Massachusetts, 01760, United States
| Watertown, Massachusetts, 02472, United States
| Pascagoula, Mississippi, 39581, United States
| Saint Louis, Missouri, 63128, United States
| Las Vegas, Nevada, 89123, United States
| Berlin, New Jersey, 08009, United States
| New York, New York, 10128, United States
| Rochester, New York, 14618, United States
| Williamsville, New York, 14221, United States
| Winston-Salem, North Carolina, 27103, United States
| Cincinnati, Ohio, 45242, United States
| Oklahoma City, Oklahoma, 73116, United States
| Philadelphia, Pennsylvania, 19139, United States
| Charleston, South Carolina, 29406, United States
| Rapid City, South Dakota, 57702, United States
| New Tazewell, Tennessee, 37825, United States
| Austin, Texas, 78731, United States
| Dallas, Texas, 75230, United States
| Houston, Texas, 77098, United States
| Orem, Utah, 84058, United States
| Salt Lake City, Utah, 84106, United States
| Roanoke, Virginia, 24018, United States
| Bellevue, Washington, 98007, United States
Location Countries

United States

Verification Date

February 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Oxycodone DETERx

Type: Experimental

Label: Placebo

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov