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

Phase 3

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
BTDS	Buprenorphine transdermal patch	Buprenorphine transdermal patch 5, 10 or 20 micrograms/hour (mcg/h)
Placebo	Placebo	Placebo to match BTDS 5, 10 or 20 mcg/h

Primary Outcome Measures

Name	Time	Method
The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site.	Double-blind phase ( 28 days): reaching "inadequate analgesia" on any 2 days of the 7-day dosing periods	Inadequate analgesia: * "average pain over the last 24 hours" score for pain at primary osteoarthritis (OA) site ≥ 5 on any 2 days of any 7-day dosing period, on a scale from 0 - 10 (0 = no pain to 10 = pain as bad as you can imagine)or; * \>1000 mg/day acetaminophen for pain at primary OA site for ≥ 2 days in any 7-day dosing period, or; * ingested nonstudy opioid analgesic medication for pain at primary OA site. Score: lowest score = shortest time to inadequate analgesia; highest score = longest time to inadequate analgesia.

Secondary Outcome Measures

Name	Time	Method
Daily Maximum "Pain Right Now" Score for the Primary Osteoarthritis (OA) Pain Site	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.	The daily maximum 'pain right now' score for the primary OA pain site was calculated over the last 7-day dosing period in the double-blind phase or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. Collected prior to ingestion of acetaminophen. "Pain right now" scale score for primary OA site on a scale from 0-10 (where 0= no pain and 10= worst pain you can imagine).

Locations (42): Vista Medical Research
🇺🇸
Mesa, Arizona, United States
Arizona Research Center
🇺🇸
Phoenix, Arizona, United States
Radiant Research
🇺🇸
Phoenix, Arizona, United States
ACRC/Arizona Clinical Research
🇺🇸
Tucson, Arizona, United States
Advance Pain Medicine
🇺🇸
Bakersfield, California, United States
Eastgate Medical Center
🇺🇸
Cypress, California, United States
University Osteoporosis Ctr
🇺🇸
Loma Linda, California, United States
San Diego Arthritis & Osteoporosis Medical Clinic
🇺🇸
San Diego, California, United States
Scripps Clinic Rancho Bernard
🇺🇸
San Diego, California, United States
CNS Clinical Trials, Inc
🇺🇸
San Francisco, California, United States
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Vista Medical Research
🇺🇸Mesa, Arizona, United States