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NCT01135524 · ClinicalTrials.gov registry record · Phase 3
Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase
A Phase 3 study, sponsored by Purdue Pharma.
- Terminated
- Registry status
- Phase 3
- Development phase
- 196
- Enrollment target
NCT01135524: Clinical Trial Phase 3 study, sponsored by Purdue Pharma.
NCT01135524 is a Phase 3 study that was terminated before completion, run by Purdue Pharma. The registered enrollment target is 196 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01135524, a Phase 3 study, was terminated before completion, sponsored by Purdue Pharma.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 196 participants
- Enrollment target
Study Summary
The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control.
Primary Outcome
Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.
Interventions
- DRUG Buprenorphine transdermal patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2004-04 |
| Est. Completion | 2005-08 |
| Phase | Phase 3 |
Why NCT01135524 stopped before completion
NCT01135524 is an interventional study that assigns participants to a tested intervention. The registered 196 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 (75% lower).
The record links to 0 conditions, and to 1 intervention - of which Buprenorphine transdermal patch is the first listed.
NCT01135524 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01135524 about?
NCT01135524 is a clinical study titled "Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase". The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control.
What is the current status of trial NCT01135524?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 196 participants. The study started on 2004-04. Estimated completion is 2005-08.
What interventions are being tested in trial NCT01135524?
The interventions under investigation include: Buprenorphine transdermal patch (DRUG).
Who is sponsoring clinical trial NCT01135524?
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 NCT01135524's enrollment target sits among peer trials
196 1390th of 2000 higher than 608 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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