Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain
Public ClinicalTrials.gov record NCT00312221. 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, Multicenter Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release (OxyIR) Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen, immediate release oxycodone) will be provided to all subjects in addition to study drug.
Study identification
- NCT ID
- NCT00312221
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 418 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
- Apr 2004 (Type not available)
- Primary completion
- Jul 2005 (Actual)
- Completion
- Aug 2005 (Actual)
- Last update posted
- Sep 10, 2012
2004 – 2005
United States locations
- U.S. sites
- 23
- U.S. states
- 12
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Parkway Medical Center | Birmingham | Alabama | 35215 | — |
| International Clinical Research Network | Chula Vista | California | 91910 | — |
| Clinical Trials Research | Roseville | California | 95661 | — |
| Accelovance | San Diego | California | 92108 | — |
| Torrance Clinical Research | Torrance | California | 90505 | — |
| Southern Colorado Clinic | Pueblo | Colorado | 81008 | — |
| Drug Study Institute | Jupiter | Florida | 33458 | — |
| Innovative Research of West Florida, Inc. | Largo | Florida | 33770 | — |
| International Medical Research | Ormond Beach | Florida | 32174 | — |
| Peninsula Research, Inc. | Ormond Beach | Florida | 32174 | — |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | — |
| Georgia Medical Research Institute | Marietta | Georgia | 30060 | — |
| Non- Surgical Orthopedic & Spine Center, P.C. | Marietta | Georgia | 30060 | — |
| The Arthritis Center | Springfield | Illinois | 62704 | — |
| Commonwealth Biomedical Research, LLC | Madisonville | Kentucky | 42431 | — |
| Miray Medical Center | Brockton | Massachusetts | 23010 | — |
| Professional Clinical Research Crystal Lake Health Center | Benzonia | Michigan | 49616 | — |
| Rheumatology PC | Kalamazoo | Michigan | 49009 | — |
| Pharm Quest | Greensboro | North Carolina | 27401 | — |
| The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | 19046 | — |
| Amarillo Center for Clinical Research | Amarillo | Texas | 79124 | — |
| Med Search Professional Group/Pharmaceutical C-Trials Inc. | Hurst | Texas | 76054 | — |
| Texas Medical Research Associates | San Antonio | Texas | 78238 | — |
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 NCT00312221, 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 10, 2012 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00312221 live on ClinicalTrials.gov.