Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.
Public ClinicalTrials.gov record NCT00315458. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Determine Efficacy and Safety of Buprenorphine Transdermal System in Subjects With Moderate To Severe Osteoarthritis Pain Requiring Daily Treatment With Opioids
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00315458
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 107 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2003
- Primary completion
- Feb 28, 2005
- Completion
- Feb 28, 2005
- Last update posted
- Sep 2, 2012
2003 – 2005
United States locations
- U.S. sites
- 48
- U.S. states
- 23
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Parkway Medical Center | Birmingham | Alabama | 35215 | — |
| Clinical Research Consultants | Birmingham | Alabama | 35244 | — |
| Winston Physician Services, Inc | Haleyville | Alabama | 35565 | — |
| Private Practice | Muscle Shoals | Alabama | 35661 | — |
| Clinic for Rheumatic Diseases | Tuscaloosa | Alabama | 35406 | — |
| Radiant Research | Phoenix | Arizona | 85013 | — |
| Arizona Research Center | Phoenix | Arizona | 85023 | — |
| ACRC/Arizona Clinical Research | Tuscon | Arizona | 85715 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| Southbay Pharma Research | Buena Park | California | 90620 | — |
| Torrence Clinical Research | Torrance | California | 90505 | — |
| Comprehensive Neuroscience Inc | Boynton Beach | Florida | 33437 | — |
| Chiefland Medical Center | Chiefland | Florida | 32626 | — |
| University Clinical Research Deland | DeLand | Florida | 32720 | — |
| Florida Medical Research Institute | Gainesville | Florida | 32605 | — |
| Drug Study Institute | Jupiter | Florida | 33458 | — |
| Coastal Medical Research | Orange City | Florida | 32763 | — |
| Ormond Medical Arts Pharmaceutical Res Ctr | Ormond Beach | Florida | 32174 | — |
| The Arthritis Center | Palm Harbor | Florida | 34684 | — |
| Avancia Research | Pembroke Pines | Florida | 33024 | — |
| Coastal Medical Research | Port Orange | Florida | 32127 | — |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | — |
| Gold Coast Research LLC | Weston | Florida | 33321 | — |
| Georgia Medical Research Institute | Marietta | Georgia | 30060 | — |
| Internal Medicine Northwest | Gurnee | Illinois | 60031 | — |
| MediSphere Medical Research Center | Evansville | Indiana | 47714 | — |
| University of Louisville Medical/Rheumatology | Louisville | Kentucky | 40202 | — |
| Clinical Trials Management, LLC | Metairie | Louisiana | 70006 | — |
| Future Care Studies | Springfield | Massachusetts | 01107 | — |
| Bay Area Health Clinic | Bay City | Michigan | 48706 | — |
| Medex Healthcare Research Inc | St Louis | Missouri | 63108 | — |
| Beth Israel Medical Center | New York | New York | 10003 | — |
| Health Research Institute | Oklahoma City | Oklahoma | 73109 | — |
| Keystone Clinical Solutions | Altoona | Pennsylvania | 16602 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| BioMedical Research Associates | Shippensburg | Pennsylvania | 17257 | — |
| University Orthopedics Center | State College | Pennsylvania | 16801 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| Low Country Rheumatology | Charleston | South Carolina | 29406 | — |
| Brown Clinic | Watertown | South Dakota | 57201 | — |
| Holston Medical Group | Bristol | Tennessee | 37620 | — |
| CSS Research | Memphis | Tennessee | 38119 | — |
| Prime Care Medical Center | Selmer | Tennessee | 38375 | — |
| Team Research of Central Texas | Harker Heights | Texas | 76548 | — |
| Quality Research | San Antonio | Texas | 78209 | — |
| Advanced Pain Management and Rehab Hilltop Med Center | Virginia Beach | Virginia | 23454 | — |
| Sentara Medical Group | Virginia Beach | Virginia | 23462 | — |
| Physicians Clinic of Spokane | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00315458, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2012 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00315458 live on ClinicalTrials.gov.