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NCT01141283 · ClinicalTrials.gov registry record · Phase 3
Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase
A Phase 3 study of Osteoarthritis, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 290
- Enrollment target
- 20
- Study locations
NCT01141283: Completed Phase 3 study of Osteoarthritis, sponsored by Purdue Pharma.
NCT01141283 is a Phase 3 study of Osteoarthritis that has completed, run by Purdue Pharma. The registered enrollment target is 290 participants, below the 816-participant average among 135 other Osteoarthritis trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01141283, a Phase 3 study of Osteoarthritis, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 290 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).
Primary Outcome
Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.
Conditions Studied
Interventions
- DRUG Buprenorphine transdermal patch
Study Locations (20)
Florida
- Research Facility - Atlantis
- Allergy, Asthma, Arthritis & Lung - Daytona Beach
- University Clinical Research Deland - DeLand
- Research Facility - Jupiter
- Coastal Medical Research - Orange City
- Research Facility - Plantation
- Research Facility - West Palm Beach
Arizona
- Vista Medical Research Inc. - Mesa
- Arthrocare, Arthritis Care and Research - Phoenix
- Arizona Rheumatology Ctr and Phoenix Ctr for Clinical Research - Phoenix
- Arizona Research Center - Phoenix
- Research Facility - Tucson
California
- Advanced Pain Medicine - Bakersfield
- Orange County Clinical Research - Cypress
- San Diego Arthritis & Osteoporosis Medical Clinic - San Diego
- Research Facility - San Diego
- Research Facility - San Francisco
Colorado
- Research Facility - Denver
- Research Facility - Westminster
Connecticut
- Research Facility - Bridgeport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2003-04 |
| Est. Completion | 2004-07 |
| Phase | Phase 3 |
What the finished NCT01141283 record still lists
NCT01141283 is an interventional study that assigns participants to a tested intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap, below the 816-participant average among 135 other Osteoarthritis trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Osteoarthritis appearing as the primary indexed condition, and to 1 intervention - of which Buprenorphine transdermal patch is the first listed.
NCT01141283 names 20 study sites across 5 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT01141283 about?
NCT01141283 is a clinical study titled "Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase". The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).
What is the current status of trial NCT01141283?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 290 participants. The study started on 2003-04. Estimated completion is 2004-07.
What conditions does trial NCT01141283 study?
This clinical trial studies the following conditions: Osteoarthritis.
What interventions are being tested in trial NCT01141283?
The interventions under investigation include: Buprenorphine transdermal patch (DRUG).
Who is sponsoring clinical trial NCT01141283?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01141283 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteoarthritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01141283's enrollment target sits among peer trials
290 41st of 135 higher than 95 of 135 other Osteoarthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis 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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