Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT00315848
First received: April 18, 2006
Last updated: April 29, 2006
Last verified: April 2006

April 18, 2006
April 29, 2006
November 1996
Not Provided
Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or at early termination.
Same as current
Complete list of historical versions of study NCT00315848 on ClinicalTrials.gov Archive Site
  • Brief Pain Inventory
  • dropouts due to lack of efficacy
  • MOS health survey
  • VAS pain intensity
  • therapeutic response
  • patient preference
  • daily patient diary
  • and number of oxycodone/acetaminophen or placebo tablets taken
  • brief Pain Inventory,
  • dropouts due to lack of efficacy
  • MOS health survey, VAS pain intensity
  • therapeutic response
  • patient preference
  • daily patient diary
  • number of oxycodone/acetaminophen or placebo tablets taken
Not Provided
Not Provided
 
The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Osteoarthritis
Drug: Buprenorphine transdermal delivery system
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
December 1999
Not Provided

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00315848
BP96-0101
Not Provided
Not Provided
Purdue Pharma LP
Not Provided
Not Provided
Purdue Pharma LP
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP