Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.
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
- clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids.
- taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain.
Exclusion criteria
- requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine.
- scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period.
Other protocol-specific exclusion/inclusion criteria may apply.
Trial design
Primary purpose
Allocation
Interventional model
Masking
107 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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