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NCT00315458 · ClinicalTrials.gov registry record · Phase 3
Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.
A Phase 3 study, sponsored by Purdue Pharma.
- Terminated
- Registry status
- Phase 3
- Development phase
- 107
- Enrollment target
NCT00315458: Clinical Trial Phase 3 study, sponsored by Purdue Pharma.
NCT00315458 is a Phase 3 study that was terminated before completion, run by Purdue Pharma. The registered enrollment target is 107 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00315458, a Phase 3 study, was terminated before completion, sponsored by Purdue Pharma.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 107 participants
- Enrollment target
Study Summary
The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.
Primary Outcome
For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.
Interventions
- DRUG Placebo transdermal patch
- DRUG Buprenorphine transdermal patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2003-12 |
| Est. Completion | 2005-03 |
| Phase | Phase 3 |
Why NCT00315458 stopped before completion
NCT00315458 is an interventional study that assigns participants to a tested intervention. The registered 107 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 (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo transdermal patch is the first listed.
NCT00315458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00315458 about?
NCT00315458 is a clinical study titled "Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.". The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the...
What is the current status of trial NCT00315458?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 107 participants. The study started on 2003-12. Estimated completion is 2005-03.
What interventions are being tested in trial NCT00315458?
The interventions under investigation include: Placebo transdermal patch (DRUG), Buprenorphine transdermal patch (DRUG).
Who is sponsoring clinical trial NCT00315458?
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 NCT00315458's enrollment target sits among peer trials
107 1666th of 2000 higher than 335 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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