Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.
Public ClinicalTrials.gov record NCT00320801. 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.
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Official title
A Randomized, Double-Blind, Multicenter Study Evaluating The Safety and Efficacy of BTDS in Subjects With Moderate to Severe Osteoarthritis Pain. Includes a 52-Week Extension Phase.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h 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 or ibuprofen) will be provided to all subjects in addition to study drug. This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.
Study identification
- NCT ID
- NCT00320801
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 188 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
- Jan 2004 (Type not available)
- Primary completion
- Mar 2005 (Actual)
- Completion
- Mar 2005 (Actual)
- Last update posted
- Sep 3, 2012
2004 – 2005
United States locations
- U.S. sites
- 66
- U.S. states
- 24
- U.S. cities
- 58
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Parkway Medical Center | Birmingham | Alabama | 35215 | — |
| Edwards Lake Medical Center | Birmingham | Alabama | 35235 | — |
| Rheumatogogy Associates of N. Alabama, | Huntsville | Alabama | 35801 | — |
| Drug Research and Analysis Corp. | Montgomery | Alabama | 36106 | — |
| Meadowbrook Research | Scottsdale | Arizona | 85251 | — |
| Research Solutions, LLC | Searcy | Arizona | 72143 | — |
| Central Arkansas Research | Hot Springs | Arkansas | 71913 | — |
| Crest Clinical Research, Inc | Anaheim | California | 92804 | — |
| NuLife Clinical Research, Inc. | Anaheim | California | 92805 | — |
| Orange County Clinical Research | Cypress | California | 90630 | — |
| Private Practice | Laguna Hills | California | 90404 | — |
| Andwell Research | Laguna Niguel | California | 92677 | — |
| Valerius Medical Group & Research Center Inc. | Long Beach | California | 90802 | — |
| Anesthesiology and Pain Management | Los Gatos | California | 95032 | — |
| Scripps Clinic Ranchro Bernardo | San Diego | California | 92128 | — |
| Orrin M. Troum & Medical Associates | Santa Monica | California | 90404 | — |
| Diablo Clinical Research | Walnut Creek | California | 94598 | — |
| Private Practice | Arvada | Colorado | 80005 | — |
| Mountainview Clinical Research | Denver | Colorado | 80209 | — |
| Private Practice | Aventura | Florida | 33180 | — |
| Medical Research Associates | Clearwater | Florida | 33761 | — |
| LifeSpan Clinical Research | Miami | Florida | 33186 | — |
| Ocala Rheumatology Research Center | Ocala | Florida | 34474 | — |
| Family Practice of St. Cloud PA Wilker/Powers Center for Clinical Studies | Saint Cloud | Florida | 34769 | — |
| Wilker/Powers Center for Clinical Studies | Saint Cloud | Florida | 34769 | — |
| Sarasota Arthritis Center | Sarasota | Florida | 34239 | — |
| University Neurology | Sarasota | Florida | 34243 | — |
| Pinnacle Trials, Inc. | Atlanta | Georgia | 30329 | — |
| Clinical Investigative Services Med College of Georgia | Augusta | Georgia | 30912 | — |
| America's Doctor (SMO) | Gurnee | Illinois | 60031 | — |
| Dolby Providers, Inc. | New Orleans | Louisiana | 70128 | — |
| Professional Clinical Research | Cadillac | Michigan | 49601 | — |
| Private Practice | Oak Park | Michigan | 48237 | — |
| Lake Michigan Clinical Research and Consulting, Inc. | Saint Joseph | Michigan | 49085 | — |
| Research Center of the Ozarks, , MO | Everton | Missouri | 65646 | — |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | — |
| Cherry Hill Orthopedic Surgeons | Cherry Hill | New Jersey | 08002 | — |
| Private Practice | Medford | New Jersey | 08055 | — |
| Univeristy of Medicine and Dentistry of New Jersey | Stratford | New Jersey | 08084 | — |
| Crescent Medical Assoc. | Astoria | New York | 11102 | — |
| Private Practice | Plainview | New York | 11803 | — |
| State University of NY at Stonybrook | Stony Brook | New York | 11794 | — |
| Charlotte Spine Center Pain and Orthopedic Neurology, Pain Research Institute of the Carolinas | Charlotte | North Carolina | 28207 | — |
| Albermarle Family Practice | Elizabeth City | North Carolina | 27909 | — |
| New Hanover Medical Research | Wilmington | North Carolina | 28412 | — |
| Odyssey Research Services | Bismarck | North Dakota | 58501 | — |
| Midwest Regional Research | Bellbrook | Ohio | 45305 | — |
| COR Clinical Research, LLC | Oklahoma City | Oklahoma | 73103 | — |
| Lyle, Austin Alexander PA | Tulsa | Oklahoma | 74104 | — |
| Rouge Valley Clinical Research | Medford | Oregon | 97504 | — |
| Southern Oregon Health & Wellness | Medford | Oregon | 97504 | — |
| Keystone Clinical Solutions, Inc. | Altoona | Pennsylvania | 16602 | — |
| Sidney Hillman Medical Center | Philadelphia | Pennsylvania | 19103 | — |
| Arcuri Clinical Research | Philadelphia | Pennsylvania | 19142 | — |
| The Arthritis & Osteoporosis Center | Orangeburg | South Carolina | 29118 | — |
| Alpha Clinical Research | Clarksville | Tennessee | 37043 | — |
| Holston Medical Group | Kingsport | Tennessee | 37660 | — |
| Integrity Clinical Research, LLC (SMO) | Milan | Tennessee | 38358 | — |
| LifeTree Clinical Reseach | Salt Lake City | Utah | 84106 | — |
| J. Lewis Research Foothill Family Clinic | Salt Lake City | Utah | 84109 | — |
| J. Lewis Research Foothill Family Clinic South | Salt Lake City | Utah | 84121 | — |
| Arthritis Clinic of No. Virginia | Arlington | Virginia | 22205 | — |
| MedSource | Richmond | Virginia | 23229 | — |
| Vantage Clinical Research Group | Lacey | Washington | 98516 | — |
| Arthritis Northwest | Seattle | Washington | 98166 | — |
| Clinical Trials Northwest | Yakima | Washington | 98902 | — |
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 NCT00320801, 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 3, 2012 · Synced Nov 10, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00320801 live on ClinicalTrials.gov.