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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

August 1, 2011

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

August 30, 2011

First Submitted That Met QC Criteria

August 31, 2011

First Posted (ESTIMATE)

September 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 12, 2015

Last Update Submitted That Met QC Criteria

February 11, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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