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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 is a Phase 3 study that was terminated before completion, run by Purdue Pharma. The registered enrollment target is 107 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00315458
The ClinicalTrials.gov registry entry for NCT00315458 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 107 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 Placebo transdermal patch is the first listed.
NCT00315458 reports 0 study locations.
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.
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