Overview
Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015
Status:
Terminated
Terminated
Trial end date:
2008-01-01
2008-01-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose [up to BTDS 20 micrograms (mcg) / hour (h)] depending on adequate pain relief and tolerability.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Purdue Pharma LPTreatments:
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.
- For subjects entering the extension, 4 electrocardiograms (ECGs) are required at entry
if none were collected prior to randomization while on BTDS 20. NOTE: Subjects with
any 1 QT data corrected for heart rate using the Fridericia formula (QTcF) interval ≥
500 milliseconds (msec) would be discontinued from the extension phase
Exclusion Criteria:
- Subjects requiring long-acting opioid analgesics [once- or twice-daily dosing with a
every (q) 24 hours (h) or q12h drug] or transdermal fentanyl during the extension
phase should be discontinued from the study.