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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 is a Phase 2 study that was terminated before completion, run by Purdue Pharma. The registered enrollment target is 10 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00403234
The ClinicalTrials.gov registry entry for NCT00403234 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Purdue Pharma, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Buprenorphine transdermal patch is the first listed.
NCT00403234 reports 0 study locations.
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.
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