A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

February 11, 2015 updated by: Purdue Pharma LP

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy

The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and opioid-induced constipation who require around-the-clock opioid therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Alabaster, Alabama, United States, 35007
        • Investigational Site
      • Birmingham, Alabama, United States, 35216
        • Investigational Site
      • Birmingham, Alabama, United States, 35213
        • Investigational Site
      • Foley, Alabama, United States, 36535
        • Investigational Site
      • Mobile, Alabama, United States, 36608
        • Investigational Site
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Investigational Site
      • Phoenix, Arizona, United States, 85020
        • Investigational Site
      • Phoenix, Arizona, United States, 85021
        • Investigational Site
      • Sun Lakes, Arizona, United States, 85248
        • Investigational Site
      • Tucson, Arizona, United States, 85704
        • Investigational Site
      • Tucson, Arizona, United States, 85712
        • Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Investigational Site
      • Sherwood, Arkansas, United States, 72120
        • Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Investigational Site
      • Anaheim, California, United States, 92804
        • Investigational Site
      • Artesia, California, United States, 90701
        • Investigational Site
      • Cerritos, California, United States, 90703
        • Investigational Site
      • Chino, California, United States, 91710
        • Investigational Site
      • El Cajon, California, United States, 92020
        • Investigational Site
      • Encino, California, United States, 91436
        • Investigational Site
      • Fountain Valley, California, United States, 92708
        • Investigational Site
      • Fresno, California, United States, 93720
        • Investigational Site
      • Garden Grove, California, United States, 92843
        • Investigational Site
      • Garden Grove, California, United States, 92844
        • Investigational Site
      • Laguna Hills, California, United States, 92653
        • Investigational Site
      • Lakewood, California, United States, 90712
        • Investigational Site
      • Lincoln, California, United States, 95648
        • Investigational Site
      • Lomita, California, United States, 90717
        • Investigational Site
      • Long Beach, California, United States, 90806
        • Investigational Site
      • Oceanside, California, United States, 92054
        • Investigational Site
      • Orange, California, United States, 92868
        • Investigational Site
      • Paramount, California, United States, 90723
        • Investigational Site
      • Sacramento, California, United States, 95823
        • Investigational Site
      • San Bernardino, California, United States, 92408
        • Investigational Site
      • San Diego, California, United States, 92114
        • Investigational Site
      • San Diego, California, United States, 92103
        • Investigational Site
      • Thousand Oaks, California, United States, 91360
        • Investigational Site
      • Torrance, California, United States, 90509
        • Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Investigational Site
      • Colorado Springs, Colorado, United States, 80909
        • Investigational Site
      • Denver, Colorado, United States, 80246
        • Investigational Site
      • Golden, Colorado, United States, 80401
        • Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Investigational Site
      • Bradenton, Florida, United States, 34209
        • Investigational Site
      • Chiefland, Florida, United States, 32626
        • Investigational Site
      • Clermont, Florida, United States, 34711
        • Investigational Site
      • Daytona Beach, Florida, United States, 32117
        • Investigational Site
      • Deland, Florida, United States, 32720
        • Investigational Site
      • Edgewater, Florida, United States, 32132
        • Investigational Site
      • Ft. Lauderdale, Florida, United States, 33316
        • Investigational Site
      • Ft. Myers, Florida, United States, 33916
        • Investigational Site
      • Hialeah, Florida, United States, 33012
        • Investigational Site
      • Hialeah, Florida, United States, 33010
        • Investigational Site
      • Inverness, Florida, United States, 34452
        • Investigational Site
      • Jacksonville, Florida, United States, 32256
        • Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Investigational Site
      • Jacksonville, Florida, United States, 32257
        • Investigational Site
      • Miami, Florida, United States, 33136
        • Investigational Site
      • Miami, Florida, United States, 33125
        • Investigational Site
      • Miami, Florida, United States, 33126
        • Investigational Site
      • Miami, Florida, United States, 33135
        • Investigational Site
      • Miami, Florida, United States, 33185
        • Investigational Site
      • Miami, Florida, United States, 33144
        • Investigational Site
      • Miami, Florida, United States, 33015
        • Investigational Site
      • Miami, Florida, United States, 33145
        • Investigational Site
      • Miami, Florida, United States, 33155
        • Investigational Site
      • Miami, Florida, United States, 33165
        • Investigational Site
      • Miami Beach, Florida, United States, 33140
        • Investigational Site
      • Naples, Florida, United States, 34110
        • Investigational Site
      • Naples, Florida, United States, 34113
        • Investigational Site
      • New Smyrna Beach, Florida, United States, 32168
        • Investigational Site
      • North Miami, Florida, United States, 33161
        • Investigational Site
      • Oldsmar, Florida, United States, 34677
        • Investigational Site
      • Orlando, Florida, United States, 32806
        • Investigational Site
      • Oviedo, Florida, United States, 32765
        • Investigational Site
      • Plantation, Florida, United States, 33317
        • Investigational Site
      • Tamarac, Florida, United States, 33321
        • Investigational Site
      • Tampa, Florida, United States, 33607
        • Investigational Site
      • West Palm Beach, Florida, United States, 33409
        • Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Investigational Site
      • Austell, Georgia, United States, 30106
        • Investigational Site
      • Snellville, Georgia, United States, 30078
        • Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83704
        • Investigational Site
      • Boise, Idaho, United States, 83713
        • Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Investigational Site
      • Chicago, Illinois, United States, 60616
        • Investigational Site
      • Chicago, Illinois, United States, 60622
        • Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Investigational Site
      • Indianapolis, Indiana, United States, 46250
        • Investigational Site
      • Michigan City, Indiana, United States, 46360
        • Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67203
        • Investigational Site
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Investigational Site
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Investigational Site
      • Monroe, Louisiana, United States, 71201
        • Investigational Site
      • New Orleans, Louisiana, United States, 70119
        • Investigational Site
    • Maryland
      • Pikesville, Maryland, United States, 21208
        • Investigational Site
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Investigational Site
      • Worcester, Massachusetts, United States, 01605
        • Investigational Site
    • Missouri
      • Florissant, Missouri, United States, 63031
        • Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Investigational Site
    • New Jersey
      • Atco, New Jersey, United States, 08004
        • Investigational Site
    • New York
      • Great Neck, New York, United States, 11023
        • Investigational Site
      • Kew Gardens, New York, United States, 11415
        • Investigational Site
      • New York, New York, United States, 10023
        • Investigational Site
      • Rochester, New York, United States, 14618
        • Investigational Site
      • Williamsville, New York, United States, 14221
        • Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Investigational Site
      • Elkin, North Carolina, United States, 28621
        • Investigational Site
      • High Point, North Carolina, United States, 27262
        • Investigational Site
      • Winston Salem, North Carolina, United States, 27103
        • Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Investigational Site
      • Dayton, Ohio, United States, 45406
        • Investigational Site
      • Moraine, Ohio, United States, 45439
        • Investigational Site
      • Toledo, Ohio, United States, 43614
        • Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73119
        • Investigational Site
      • Oklahoma City, Oklahoma, United States, 73103
        • Investigational Site
      • Oklahoma City, Oklahoma, United States, 73109
        • Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Investigational Site
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • Investigational Site
      • Levittown, Pennsylvania, United States, 19056
        • Investigational Site
      • Mechanicsburg, Pennsylvania, United States, 17055
        • Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15215
        • Investigational Site
      • Red Lion, Pennsylvania, United States, 17356
        • Investigational Site
      • State College, Pennsylvania, United States, 16801
        • Investigational Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Investigational Site
      • Myrtle Beach, South Carolina, United States, 29588
        • Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Investigational Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Investigational Site
    • Texas
      • Allen, Texas, United States, 75013
        • Investigational Site
      • Austin, Texas, United States, 78731
        • Investigational Site
      • Dallas, Texas, United States, 75231
        • Investigational Site
      • Dallas, Texas, United States, 75251
        • Investigational Site
      • Dallas, Texas, United States, 75203
        • Investigational Site
      • Dallas, Texas, United States, 75218
        • Investigational Site
      • Houston, Texas, United States, 77065
        • Investigational Site
      • Houston, Texas, United States, 77074
        • Investigational Site
      • Houston, Texas, United States, 77098
        • Investigational Site
      • Houston, Texas, United States, 77062
        • Investigational Site
      • McKinney, Texas, United States, 75070
        • Investigational Site
      • North Richland Hills, Texas, United States, 76180
        • Investigational Site
      • Tomball, Texas, United States, 77375
        • Investigational Site
    • Utah
      • Orem, Utah, United States, 84058
        • Investigational Site
      • Salt Lake City, Utah, United States, 84102
        • Investigational Site
      • Salt Lake City, Utah, United States, 84124
        • Investigational Site
    • Virginia
      • Danville, Virginia, United States, 24541
        • Investigational Site
      • Midlothian, Virginia, United States, 23114
        • Investigational Site
      • Richmond, Virginia, United States, 23220
        • Investigational Site
    • Washington
      • Bothell, Washington, United States, 98011
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria include:

  • Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period;
  • The low back pain must be related to nonmalignant and nonneuropathic conditions and may be with or without radiation;
  • Subjects must have a self-reported history of opioid induced constipation (OIC).

Exclusion Criteria include:

  • Subjects with rheumatoid arthritis or other inflammatory arthritis;
  • Subjects with neuropathic conditions that have been painful or required therapy within the past 3 months;
  • Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract or other significant conditions affecting GI motility;
  • Subjects with chronic constipation not related to opioid use;
  • Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or planned during the study;
  • Subjects with a history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated.

Other protocol specific inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: OXN
Oxycodone/Naloxone controlled-release tablets (OXN)
Drug: Oxycodone/Naloxone controlled-release
Oxycodone/Naloxone controlled-release tablets (10/5 - 40/20 mg) taken orally every 12 hours
ACTIVE_COMPARATOR: OXY
Oxycodone HCl controlled-release tablets (OXY)
Drug: Oxycodone HCl controlled-release
Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours
Other Names:
  • OxyContin
PLACEBO_COMPARATOR: Placebo
Placebo tablets to match OXN or OXY
Drug: Placebo
Placebo tablets to match OXN or OXY taken orally every 12 hours

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall complete spontaneous bowel movement (CSBM) responder rates
Time Frame: Weeks 1 through 12
The overall Complete Spontaneous Bowel Movement (CSBM) responder rates over the 12 week double-blind period comparing OXN to OXY
Weeks 1 through 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
CSBM Responder at least 50% of the weeks in the double-blind period
Time Frame: Weeks 1 through 12
Weeks 1 through 12
Laxative-free Responder at least 50% of the weeks in the double-blind period
Time Frame: Weeks 1 through 12
Weeks 1 through 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Purdue Pharma LP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ONU3705
  • 2011-005061-20 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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