Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Purdue Pharma LP
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
