Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Pain, Osteoarthritis of the Knee

In brief

The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.

Key facts

Study ID

NCT00531427

Run by

Purdue Pharma LP

People needed

567

Starts

2007-09-01

Expected to finish

2009-11-01

Last updated by the study team

2012-09-10

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• subjects with moderate to severe chronic osteoarthritis (OA) pain of the knee (lasting several hours daily) as their predominant pain condition,
• clinical diagnosis of OA of the knee 1 year or longer,
• subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of < 5 mg oxycodone (or equivalent) per day,
• subjects whose OA knee pain is not adequately controlled with nonopioid analgesic medication and who the investigator feels are appropriate candidates for around-the-clock opioid therapy.

You may not qualify if…

• subjects who have had arthroscopy on either knee or hip within 6 months of entering the study or open surgery on either knee or hip within 9 months of entering the study,
• subjects who are allergic to buprenorphine or who have a history of allergies to other opioids,
• subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.
• Other protocol-specific inclusion/exclusion criteria may apply.

Where it is running

• Radiant Research, Phoenix Southeast — Chandler, Arizona, United States
• Arizona Research Center, Inc. — Phoenix, Arizona, United States
• Research Facility — Phoenix, Arizona, United States
• Research Facility — Phoenix, Arizona, United States
• Research Facility — Anaheim, California, United States
• Lovelace Scientific Resources, Inc. — Beverly Hills, California, United States
• Catalina Research Institute — Chino, California, United States
• Research Facility — Downey, California, United States
• Research Facility — Foothill Ranch, California, United States
• Research Facility — Laguna Hills, California, United States
• Research Facility — Sacramento, California, United States
• Research Facility — Littleton, Colorado, United States
• Research Facility — Stamford, Connecticut, United States
• Coastal Pain Management — Bradenton, Florida, United States
• Clinical Research of West Florida — Clearwater, Florida, United States
• Research Facility — Clearwater, Florida, United States
• Research Facility — Jupiter, Florida, United States
• Research Facility — Largo, Florida, United States
• Pharmax Research Clinic — Miami, Florida, United States
• Research Facility — Miami, Florida, United States
• Research Facility — Orlando, Florida, United States
• Research Facility — Plantation, Florida, United States
• Research Facility — Royal Palm Hammock, Florida, United States
• Clinical Research of West Flor — Tampa, Florida, United States
• Coastal Clinical Research, Inc. — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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