Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase

• Status: Completed
• Trial end date: 2004-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Purdue Pharma LP
• Treatments: Buprenorphine

Criteria

Inclusion Criteria:

• Subjects with moderate to severe osteoarthritic (OA) pain who completed all visits of the double-blind phase on study drug, or who discontinued study drug due to lack of therapeutic effect in the double-blind phase, but still completed all visits of the double-blind phase off study drug, are eligible to enroll in the extension phase.

Exclusion Criteria:

• Excluded from the study are subjects who ingest > 2500 mg/day acetaminophen as part of their current stable nonopioid analgesic regimen.

• Subjects requiring long-acting opioid analgesics [once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug] or transdermal fentanyl during the extension phase should be discontinued from the study.

Refer to core study for additional inclusion/exclusion information.