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Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase
NCT01141283 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01141283
The ClinicalTrials.gov registry entry for NCT01141283 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 290 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Purdue Pharma, which has 13 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01141283 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01141283?
The interventions under investigation include: Buprenorphine transdermal patch (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01141283?
This trial is sponsored by Purdue Pharma, which has 13 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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