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

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”

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.

Buprenorphine is a synthetic opioid analgesic with over 25 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.

Intervention(s) in this Clinical Trial

• Drug: Buprenorphine transdermal patch
  • Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
• Drug: Placebo
  • Placebo to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: BTDS
  • Buprenorphine transdermal patch 5, 10 or 20 micrograms/hour (mcg/h)
• Placebo Comparator: Placebo
  • Placebo to match BTDS 5, 10 or 20 mcg/h

Primary Measures

• The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site.
  • Time Frame: Double-blind phase ( 28 days): reaching "inadequate analgesia" on any 2 days of the 7-day dosing periods
    Safety Issue?: No

Secondary Measures

• Daily Maximum "Pain Right Now" Score for the Primary Osteoarthritis (OA) Pain Site
  • Time Frame: 7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase.
    Safety Issue?: No

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 milligrams (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 Investigator: Purdue Pharma LP Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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