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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01358526
The ClinicalTrials.gov registry entry for NCT01358526 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,095 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 495-participant average among 122 other Low Back Pain trials with a reported enrollment target (121% higher). The listed sponsor is Purdue Pharma, which has 54 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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