Safety of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Pain Following Orthopedic Surgery.

• Status: Completed
• Trial end date: 1997-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe pain after orthopedic surgery. The double-blind treatment intervention duration is 72 hours during which time supplemental analgesic medication (intravenous morphine PCA) will be provided to all subjects in addition to study drug.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Purdue Pharma LP
• Treatments: Buprenorphine

Criteria

Inclusion Criteria:

• underwent any major orthopedic surgical procedure requiring general anesthesia, and were expected to be hospitalized >/=4 days postoperatively.

• in moderate or greater pain post-recovery from anesthesia and were expected to be in, or greater than, moderate pain, without analgesics, for >/=4 days post-surgery.

Exclusion Criteria:

• receiving chronic opioid therapy preoperatively for >1 month that was at a total daily dose of >/= 60 mg of oral morphine equivalents.

• have significant concurrent pulmonary conditions.

Other protocol-specific exclusion/inclusion criteria may apply.