Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00312572 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain
A Phase 3 study, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 204
- Enrollment target
NCT00312572: Completed Phase 3 study, sponsored by Purdue Pharma.
NCT00312572 is a Phase 3 study that has completed, run by Purdue Pharma. The registered enrollment target is 204 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00312572, a Phase 3 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 204 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.
Primary Outcome
The indicator variable was 1 = completion, and 0 = noncompletion. For the primary efficacy analysis, the percentage of subjects who completed the double-blind phase was computed with its 95% confidence interval (CI) for each treatment regimen (starting dose of BTDS 10 or BTDS 20) across and within baseline Vicodin® stratum (15 to 22.5mg/day vs \>22.5 to 30 mg/day as determined by the daily average hydrocodone dose during the run-in period).
Interventions
- DRUG Buprenorphine transdermal patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2003-06 |
| Est. Completion | 2004-07 |
| Phase | Phase 3 |
What the finished NCT00312572 record still lists
NCT00312572 is an interventional study that assigns participants to a tested intervention. The registered 204 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 (74% lower).
The record links to 0 conditions, and to 1 intervention - of which Buprenorphine transdermal patch is the first listed.
NCT00312572 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00312572 about?
NCT00312572 is a clinical study titled "Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain". The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks dur...
What is the current status of trial NCT00312572?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 204 participants. The study started on 2003-06. Estimated completion is 2004-07.
What interventions are being tested in trial NCT00312572?
The interventions under investigation include: Buprenorphine transdermal patch (DRUG).
Who is sponsoring clinical trial NCT00312572?
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 NCT00312572's enrollment target sits among peer trials
204 1352nd of 2000 higher than 649 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03481010 · 204 participants · NA
Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology
- NCT04249830 · 204 participants · NA
Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Young Adults
- NCT04503395 · 204 participants · NA
ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES
- NCT04793776 · 204 participants · NA
Manage Emotions to Reduce Aggression (MERA)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia