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NCT00403234 · ClinicalTrials.gov registry record · Phase 2
Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement
A Phase 2 study, sponsored by Purdue Pharma.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT00403234: Clinical Trial Phase 2 study, sponsored by Purdue Pharma.
NCT00403234 is a Phase 2 study that was terminated before completion, run by Purdue Pharma. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00403234, a Phase 2 study, was terminated before completion, sponsored by Purdue Pharma.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative measures after total knee replacement surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind treatment period is for 28 days during which time supplemental analgesic medication will be provided to all subjects in addition to study drug. Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to efficacy or safety. The focus of this study became safety evaluations.
Primary Outcome
Adverse Events that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved.
Interventions
- DRUG Buprenorphine transdermal patch
- DRUG Placebo BTDS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2006-11 |
| Est. Completion | 2007-08 |
| Phase | Phase 2 |
Why NCT00403234 stopped before completion
NCT00403234 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Buprenorphine transdermal patch is the first listed.
NCT00403234 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00403234 about?
NCT00403234 is a clinical study titled "Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement". The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative measures after total knee replacement surgery; and 3) the safety of BTDS...
What is the current status of trial NCT00403234?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2006-11. Estimated completion is 2007-08.
What interventions are being tested in trial NCT00403234?
The interventions under investigation include: Buprenorphine transdermal patch (DRUG), Placebo BTDS (DRUG).
Who is sponsoring clinical trial NCT00403234?
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 NCT00403234's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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