Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug.
This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- osteoarthritis of the hip, knee, or spine for 1 year or longer.
- taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week.
Exclusion criteria
- taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
- requiring frequent analgesic therapy for chronic conditions in addition to osteoarthritis.
Other protocol-specific exclusion/inclusion criteria may apply.
Trial design
Primary purpose
Allocation
Interventional model
Masking
188 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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