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

Completed · Phase 2

Conditions studied: Postoperative Pain

In brief

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.

Key facts

Study ID

NCT00315835

Run by

Purdue Pharma LP

People needed

100

Starts

1996-10-01

Expected to finish

1997-11-01

Last updated by the study team

2006-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Park Place Therapeutic Center — Plantation, Florida, United States

Full record on ClinicalTrials.gov

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