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NCT00313014 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain
A Phase 3 study, sponsored by Purdue Pharma.
- Terminated
- Registry status
- Phase 3
- Development phase
- 660
- Enrollment target
NCT00313014: Clinical Trial Phase 3 study, sponsored by Purdue Pharma.
NCT00313014 is a Phase 3 study that was terminated before completion, run by Purdue Pharma. The registered enrollment target is 660 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00313014, a Phase 3 study, was terminated before completion, sponsored by Purdue Pharma.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 660 participants
- Enrollment target
Study Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will be provided to all subjects in addition to study drug.
Primary Outcome
Subjects were evaluated during the double-blind phase for "average pain over the last 24 hours" prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)
Interventions
- DRUG Buprenorphine
- DRUG Oxycodone Immediate-Release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2004-02 |
| Est. Completion | 2005-09 |
| Phase | Phase 3 |
Why NCT00313014 stopped before completion
NCT00313014 is an interventional study that assigns participants to a tested intervention. The registered 660 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 2 interventions - of which Buprenorphine is the first listed.
NCT00313014 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00313014 about?
NCT00313014 is a clinical study titled "Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain". The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with o...
What is the current status of trial NCT00313014?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 660 participants. The study started on 2004-02. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00313014?
The interventions under investigation include: Buprenorphine (DRUG), Oxycodone Immediate-Release (DRUG).
Who is sponsoring clinical trial NCT00313014?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00313014's enrollment target sits among peer trials
660 556th of 2000 higher than 1,440 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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