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NCT01358526 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
A Phase 3 study of Low Back Pain, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,095
- Enrollment target
- 20
- Study locations
NCT01358526: Completed Phase 3 study of Low Back Pain, sponsored by Purdue Pharma.
NCT01358526 is a Phase 3 study of Low Back Pain that has completed, run by Purdue Pharma. The registered enrollment target is 1,095 participants, above the 495-participant average among 122 other Low Back Pain trials with a reported enrollment target (121% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01358526, a Phase 3 study of Low Back Pain, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,095 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to assess the efficacy and safety of OXN compared to placebo in opioid-experienced subjects with moderate to severe pain due to chronic low back pain who require around-the-clock opioid therapy.
Primary Outcome
The "average pain over the last 24 hours" score was collected using an 11-point numerical rating scale ranging from 0 to 10; where 0=no pain and 10=pain as bad as you can imagine.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Oxycodone/Naloxone Controlled-release
Study Locations (20)
California
- Orange County Research Institute - Anaheim
- Physician Alliance Research Center - Anaheim
- Advanced Pain Research Institute - Arcadia
- Southbay Pharma Research - Buena Park
- Providence Clinical Research - Burbank
- Med Center - Carmichael
- Advanced Pain Management and Rehabilitation Medical Group, Inc. - Castro Valley
- Catalina Research Institute, LLC - Chino
- Synergy Clinical Research of Escondido - Escondido
Alabama
- Alabama Orthopaedic Center, PC - Birmingham
- Alliance Clinical Research - Birmingham
- Winston Technology Research, LLC - Haleyville
- Monte Sano Clinical Research, LLC - Huntsville
- Research Facility - Mobile
Arizona
- Radiant Research, Inc. - Chandler
- Dedicated Clinical Research - Phoenix
- Arizona Research Center - Phoenix
- Clinical Research Advantage, Inc./Tatum Highlands Medical Associates, PLLC - Phoenix
- Quality of Life Medical & Research Center, LLC - Tucson
Arkansas
- Ortho Surgeons - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,095 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
What the finished NCT01358526 record still lists
NCT01358526 is an interventional study that assigns participants to a tested intervention. Its 1,095 participants enrollment target places it among the larger protocols in the corpus, above the 495-participant average among 122 other Low Back Pain trials with a reported enrollment target (121% higher).
The record links to 1 condition, with Low Back Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01358526 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT01358526 about?
NCT01358526 is a clinical study titled "Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain". The primary objective of this study is to assess the efficacy and safety of OXN compared to placebo in opioid-experienced subjects with moderate to severe pain due to chronic low back pain who require around-the-clock opioid therapy.
What is the current status of trial NCT01358526?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,095 participants. The study started on 2011-05. Estimated completion is 2012-11.
What conditions does trial NCT01358526 study?
This clinical trial studies the following conditions: Low Back Pain.
What interventions are being tested in trial NCT01358526?
The interventions under investigation include: Placebo (DRUG), Oxycodone/Naloxone Controlled-release (DRUG).
Who is sponsoring clinical trial NCT01358526?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01358526 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Low Back Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01358526's enrollment target sits among peer trials
1,095 7th of 122 higher than 116 of 122 other Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Low Back Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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