Overview

Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase

Status:
Terminated

Trial end date:
2005-08-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Purdue Pharma LP

Treatments:

Buprenorphine

Criteria

Inclusion Criteria:

- Subjects who completed all visits of the double-blind phase on study drug and subjects
who discontinued study drug due to lack of therapeutic effect in the double-blind
phase but completed all visits of the double-blind phase off study drug are eligible
to enroll in the extension phase.

Exclusion Criteria:

- Subjects who prematurely discontinue study drug in the double-blind phase due to
adverse event, subject's choice, administrative reason or lost to follow-up are NOT
eligible to enter the extension phase

- Subjects with electrocardiograms (ECGs) that show any QT data corrected for heart rate
using Fridericia formula (QTcF) interval ≥ 500 millisecond (msec) will be discontinued
from the extension phase.

- 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.