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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
354
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
Number of Participants With Adverse Events (AEs) as a Measure of Safety
The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015).
Time frame: 52-week extension phase
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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