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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.
 
ClinicalTrials.gov Identifier: NCT00314652
Recruitment Status : Completed
First Posted : April 14, 2006
Last Update Posted : May 3, 2006
Sponsor:
Information provided by:
Purdue Pharma LP

Brief Summary:
The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with osteoarthritis pain. The double-blind treatment intervention duration is 28 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 : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo-Controlled Study of Buprenorphine Transdermal System (BTDS) in Patients With Osteoarthritis of the Hip or Knee
Study Start Date : June 1999
Study Completion Date : October 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis




Primary Outcome Measures :
  1. Percentage of patients who were treated successfully for pain management
  2. a patient fails if he or she discontinues early due to ineffective treatment or has a Patient Satisfaction Scale score of poor or fair at the final visit

Secondary Outcome Measures :
  1. Average pain intensity and patient satisfaction scores
  2. Incidence of early discontinuation due to lack of efficacy
  3. Time to early discontinuation due to lack of efficacy
  4. Dose level at end of titration
  5. Investigator's assessment of therapeutic response
  6. Diary pain scores


Information from the National Library of Medicine

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

Inclusion Criteria:

  • documented history and/or radiologic evidence of chronic osteoarthritis of the hip or knee.
  • receiving opioid therapy for osteoarthritis-related pain within the past year or have experienced pain that was inadequately controlled with a full standard dose of NSAIDs.

Exclusion Criteria:

  • receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets or capsules per day of short-acting opioid-containing products
  • scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.

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 ClinicalTrials.gov identifier (NCT number): NCT00314652


Locations
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Sponsors and Collaborators
Purdue Pharma LP

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ClinicalTrials.gov Identifier: NCT00314652    
Other Study ID Numbers: BP99-0203
First Posted: April 14, 2006    Key Record Dates
Last Update Posted: May 3, 2006
Last Verified: April 2006
Keywords provided by Purdue Pharma LP:
Osteoarthritis
chronic pain
opioid
transdermal
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists