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NCT00313846 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee
A Phase 3 study, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 529
- Enrollment target
NCT00313846 is a Phase 3 study that has completed, run by Purdue Pharma. The registered enrollment target is 529 participants.
The verdict
NCT00313846, a Phase 3 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 529 participants
- Enrollment target
Study Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.
Interventions
- DRUG Placebo
- DRUG Buprenorphine transdermal patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 529 participants |
| Start Date | 2003-04 |
| Est. Completion | 2004-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00313846
The ClinicalTrials.gov registry entry for NCT00313846 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 529 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 is the first listed.
NCT00313846 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00313846 about?
NCT00313846 is a clinical study titled "Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee". The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. ...
What is the current status of trial NCT00313846?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 529 participants. The study started on 2003-04. Estimated completion is 2004-06.
What interventions are being tested in trial NCT00313846?
The interventions under investigation include: Placebo (DRUG), Buprenorphine transdermal patch (DRUG).
Who is sponsoring clinical trial NCT00313846?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
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