Overview

The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.

Status:
Completed
Trial end date:
1999-12-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with osteoarthritis pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Purdue Pharma LP
Treatments:
Buprenorphine
Criteria
Inclusion Criteria:

- unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory
drug considered at a therapeutic and/or tolerated dose or currently taking short-acting opioid doses per day.

- taking >/=3 opioid doses per day with or without acceptable pain control.

Exclusion Criteria:

- receiving opioids at an average daily dose of greater than 60 mg of oral morphine
equivalents or subjects receiving more than 6 tablets per day of a short-acting
opioid.

- scheduled to have surgery (including dental) involving the use of post- or
preoperative analgesics or anesthetics during the study period.

Other protocol-specific exclusion/inclusion criteria may apply.