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Completed Phase 3 Interventional Results available

Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee

ClinicalTrials.gov ID: NCT00313846

Public ClinicalTrials.gov record NCT00313846. 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.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 3:08 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of the Buprenorphine Transdermal Delivery System in Subjects With Moderate to Severe Osteoarthritic Pain of Hip or Knee

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 (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

Study identification

NCT ID
NCT00313846
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Purdue Pharma LP
Industry
Enrollment
529 participants

Conditions and interventions

Eligibility (public fields only)

Age range
40 Years to 75 Years
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 2003 (Type not available)
Primary completion
Jun 2004 (Actual)
Completion
Jun 2004 (Actual)
Last update posted
Sep 3, 2012

2003 – 2004

United States locations

U.S. sites
44
U.S. states
18
U.S. cities
41
Facility City State ZIP Site status
Vista Medical Research Mesa Arizona 85206 —
Arizona Research Center Phoenix Arizona 85012 —
Radiant Research Phoenix Arizona 85013 —
Arizona Research Center Phoenix Arizona 85023 —
ACRC/Arizona Clinical Research Tucson Arizona 85715 —
Advance Pain Medicine Bakersfield California 93311 —
Eastgate Medical Center Cypress California 90623 —
University Osteoporosis Ctr Loma Linda California 92354 —
San Diego Arthritis & Osteoporosis Medical Clinic San Diego California 92108 —
Scripps Clinic Rancho Bernard San Diego California 92128 —
CNS Clinical Trials, Inc San Francisco California 94121 —
Mountain View Clinical Research Denver Colorado 80209 —
Integrative Treatment Centers/Rocky Mtn Clin Res Westminster Colorado 80021 —
Rocky Mountain Center for Clinical Research Wheat Ridge Colorado 80033 —
Stamford Therapeutic Consortium Bridgeport Connecticut 66060 —
Medical Specialists of the Palm Beaches Atlantis Florida 33462 —
University Clinical Research Deland DeLand Florida 32720 —
Drug Study Institute Jupiter Florida 33458 —
Coastal Medical Research Orange City Florida 32763 —
Coastal Medical Research Port Orange Florida 32127 —
Palm Beach Research Center West Palm Beach Florida 33409 —
Gold Coast Research Weston Florida 33331 —
Non-Surgical Orthopedic & Spine Center Marietta Georgia 30060 —
Columbus Internal Medical Associates Columbus Indiana 47201 —
MediSphere Medical Research Ctr. Evansville Indiana 47714 —
Primary Care Research Murray Kentucky 42071 —
Professional Clinical Research Cadillac Michigan 49601 —
Sound Medical At West Front Primary Care Traverse City Michigan 49684 —
Beth Israel Med Ctr Dept of Pain Medicine & Palliative Care New York New York 10003 —
All-Trials Clinical Research, LLC Winston-Salem North Carolina 27103 —
Keystone Clinical Altoona Pennsylvania 16602 —
Altoona Center for Clinical Research Duncansville Pennsylvania 16635 —
University Orthopedics Center State College Pennsylvania 16801 —
Clinical Research Center of Reading, LLP West Reading Pennsylvania 19611 —
Low Country Rheumatology Charleston South Carolina 29406 —
Brown Clinic Watertown South Dakota 57201 —
Private Practice Dallas Texas 75251 —
Team Research of Central Texas Harker Heights Texas 76548 —
Radiant Research San Antonio Northeast San Antonio Texas 78217 —
ACCU Clinical Research Trials, Inc Seguin Texas 78155 —
Wasatch Clinical Research Salt Lake City Utah 84107 —
Advance Pain Management & Rehab Virgina Beach Virginia 23454 —
Evergreen Clinical Research Associates Edmonds Washington 98026 —
Internal Medicine Northwest Tacoma Washington 98405 —

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 NCT00313846, 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 Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00313846 live on ClinicalTrials.gov.

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