Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.
Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.
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.
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.
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.