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 Mod-to-Sev Osteoarthritic Pain of Hip or Knee”

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 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 Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Buprenorphine transdermal delivery system

Primary Measures

• The time to the development of inadequate analgesia at the primary osteoarthritis pain site.

Secondary Measures

• Daily maximum pain right now scores.

Inclusion Criteria:

• clinical diagnosis of chronic osteoarthritis of the hip or knee for 1 year or longer.
• an average pain due to osteoarthritis of moderate, moderately-severe, or severe for the 14 days prior to enrollment.

Exclusion Criteria:

• ingest opioid analgesics on a daily basis.
• ingest >2500 mg acetaminophen on a daily basis.
• require <20 mg or >80 mg of morphine (or opioid equivalents) per day for control of their osteoarthritis pain.
• Other protocol-specific exclusion/inclusion criteria may apply.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Purdue Pharma LP

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00313846

Study ID Number: BUP3012

ClinicalTrials.gov Identifier: NCT00313846

Health Authority: United States: Food and Drug Administration