Overview

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.