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The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00315848
Recruitment Status : Completed
First Posted : April 19, 2006
Last Update Posted : May 3, 2006
Information provided by:
Purdue Pharma LP

Brief Summary:
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with osteoarthritis pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Buprenorphine transdermal delivery system Phase 3

Detailed Description:
Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Parallel Group Study of the Safety and Efficacy of Buprenorphine Transdermal Delivery System Vs. Oxycodone/Acetaminophen Tablets Vs. Placebo in Patients With Chronic Pain Due to Osteoarthritis
Study Start Date : November 1996
Study Completion Date : December 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Primary Outcome Measures :
  1. Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or at early termination.

Secondary Outcome Measures :
  1. Brief Pain Inventory
  2. dropouts due to lack of efficacy
  3. MOS health survey
  4. VAS pain intensity
  5. therapeutic response
  6. patient preference
  7. daily patient diary
  8. and number of oxycodone/acetaminophen or placebo tablets taken

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking </=2 short-acting opioid doses per day.
  • taking >/=3 opioid doses per day with or without acceptable pain control.

Exclusion Criteria:

  • receiving opioids at an average daily dose of greater than 60 mg of oral morphine equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid.
  • scheduled to have surgery (including dental) involving the use of post- or preoperative analgesics or anesthetics during the study period.

Other protocol-specific exclusion/inclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00315848

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United States, Alabama
Rheumatology Associates of North Alabama
Huntsville, Alabama, United States, 35801
United States, Arizona
Arizona Research and Education
Phoenix, Arizona, United States, 85012
Phoenix Center for Clinical Research
Phoenix, Arizona, United States, 85015
United States, Colorado
Western Integrated Pain Treatment Centers
Westminster, Colorado, United States, 80030
United States, Florida
Gainesville Clinical Research Center
Gainesville, Florida, United States, 32605
Park Place Therapeutic Center
Plantation, Florida, United States, 33324
United States, Indiana
MediSphere Medical Research Center, L.L.C.
Evansville, Indiana, United States, 47714
United States, New York
Stratton VA Medical Center
Albany, New York, United States, 12208
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States, 75235
Arthritis Diagnostic and Treatment Center
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Purdue Pharma LP

Layout table for additonal information Identifier: NCT00315848    
Other Study ID Numbers: BP96-0101
First Posted: April 19, 2006    Key Record Dates
Last Update Posted: May 3, 2006
Last Verified: April 2006
Keywords provided by Purdue Pharma LP:
chronic pain
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists