Osteoarthritis Clinical Trial
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.
| Verified date | August 2012 |
| Source | Purdue Pharma LP |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 188 |
| Est. completion date | March 2005 |
| Est. primary completion date | March 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
Inclusion Criteria: - osteoarthritis of the hip, knee, or spine for 1 year or longer. - taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week. Exclusion Criteria: - taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment. - requiring frequent analgesic therapy for chronic conditions in addition to osteoarthritis. Other protocol-specific exclusion/inclusion criteria may apply. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Keystone Clinical Solutions, Inc. | Altoona | Pennsylvania |
| United States | Crest Clinical Research, Inc | Anaheim | California |
| United States | NuLife Clinical Research, Inc. | Anaheim | California |
| United States | Arthritis Clinic of No. Virginia | Arlington | Virginia |
| United States | Private Practice | Arvada | Colorado |
| United States | Crescent Medical Assoc. | Astoria | New York |
| United States | Pinnacle Trials, Inc. | Atlanta | Georgia |
| United States | Clinical Investigative Services Med College of Georgia | Augusta | Georgia |
| United States | Private Practice | Aventura | Florida |
| United States | Midwest Regional Research | Bellbrook | Ohio |
| United States | Comprehensive Clinical Research | Berlin | New Jersey |
| United States | Edwards Lake Medical Center | Birmingham | Alabama |
| United States | Parkway Medical Center | Birmingham | Alabama |
| United States | Odyssey Research Services | Bismark | North Dakota |
| United States | Professional Clinical Research | Cadillac | Michigan |
| United States | Charlotte Spine Center Pain and Orthopedic Neurology, Pain Research Institute of the Carolinas | Charlotte | North Carolina |
| United States | Cherry Hill Orthopedic Surgeons | Cherry Hill | New Jersey |
| United States | Alpha Clinical Research | Clarksville | Tennessee |
| United States | Medical Research Associates | Clearwater | Florida |
| United States | Orange County Clinical Research | Cypress | California |
| United States | Mountainview Clinical Research | Denver | Colorado |
| United States | Albermarle Family Practice | Elizabeth City | North Carolina |
| United States | Research Center of the Ozarks, , MO | Everton | Missouri |
| United States | America's Doctor (SMO) | Gurnee | Illinois |
| United States | Central Arkansas Research | Hot Springs | Arkansas |
| United States | Rheumatogogy Associates of N. Alabama, | Huntsville | Alabama |
| United States | Holston Medical Group | Kingsport | Tennessee |
| United States | Vantage Clinical Research Group | Lacey | Washington |
| United States | Private Practice | Laguna Hills | California |
| United States | Andwell Research | Laguna Niguel | California |
| United States | Valerius Medical Group & Research Center Inc. | Long Beach | California |
| United States | Anesthesiology and Pain Management | Los Gatos | California |
| United States | Private Practice | Medford | New Jersey |
| United States | Rouge Valley Clinical Research | Medford | Oregon |
| United States | Southern Oregon Health & Wellness | Medford | Oregon |
| United States | LifeSpan Clinical Research | Miami | Florida |
| United States | Integrity Clinical Research, LLC (SMO) | Milan | Tennessee |
| United States | Drug Research and Analysis Corp. | Montgomery | Alabama |
| United States | Dolby Providers, Inc. | New Orleans | Louisiana |
| United States | Private Practice | Oak Park | Michigan |
| United States | Ocala Rheumatology Research Center | Ocala | Florida |
| United States | COR Clinical Research, LLC | Oklahoma City | Oklahoma |
| United States | The Arthritis & Osteoporosis Center | Orangeburg | South Carolina |
| United States | Arcuri Clinical Research | Philadelphia | Pennsylvania |
| United States | Sidney Hillman Medical Center | Philadelphia | Pennsylvania |
| United States | Private Practice | Plainview | New York |
| United States | MedSource | Richmond | Virginia |
| United States | J. Lewis Research Foothill Family Clinic | Salt Lake City | Utah |
| United States | J. Lewis Research Foothill Family Clinic South | Salt Lake City | Utah |
| United States | LifeTree Clinical Reseach | Salt Lake City | Utah |
| United States | Scripps Clinic Ranchro Bernardo | San Diego | California |
| United States | Orrin M. Troum & Medical Associates | Santa Monica | California |
| United States | Sarasota Arthritis Center | Sarasota | Florida |
| United States | University Neurology | Sarasota | Florida |
| United States | Meadowbrook Research | Scottsdale | Arizona |
| United States | Research Solutions, LLC | Searcy | Arizona |
| United States | Arthritis Northwest | Seattle | Washington |
| United States | Family Practice of St. Cloud PA Wilker/Powers Center for Clinical Studies | St. Cloud | Florida |
| United States | Wilker/Powers Center for Clinical Studies | St. Cloud | Florida |
| United States | Lake Michigan Clinical Research and Consulting, Inc. | St. Joseph | Michigan |
| United States | State University of NY at Stonybrook | Stonybrook | New York |
| United States | Univeristy of Medicine and Dentistry of New Jersey | Stratford | New Jersey |
| United States | Lyle, Austin Alexander PA | Tulsa | Oklahoma |
| United States | Diablo Clinical Research | Walnut Creek | California |
| United States | New Hanover Medical Research | Wilmington | North Carolina |
| United States | Clinical Trials Northwest | Yakima | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Purdue Pharma LP |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Number of Participants With Adverse Events (AEs) as a Measure of Safety. | Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs). | Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase) | Yes |
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