Phase 3
Completed N=189
Safety of Buprenorphine Transdermal Systems in Subjects With Chronic Nonmalignant Pain - a 28-week Extension Study
Chronic Nonmalignant Pain
Source: ClinicalTrials.gov NCT01151098 ↗
Enrolled (actual)
189
Serious AEs
8.5%
Results posted
Sep 2010
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) as a Measure of Safety. — 1; 16; 143 participants
Summary
The objective of this study was to evaluate the long-term safety and tolerability of 7-day BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain had been previously controlled by oral opioid combination therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) as a Measure of Safety. |
1; 16; 143 | — |
Eligibility Criteria
Inclusion Criteria
Include:
- Subjects of either sex aged 18 years or older.
- Subjects who have completed or discontinued the double-blind evaluation phase of study BUP3201 are eligible to continue to receive open-label BTDS in the extension.
Exclusion Criteria
Include:
- Subjects currently receiving daily morphine or oxycodone (mono-therapy).
- Subjects who are discontinued from BUP3201 due to adverse events.
- Subjects who are scheduled for surgery of the disease site (e.g. major joint replacement surgery) or any other major surgery which would fall within the study period.
Refer to core study for additional inclusion/exclusion information.
Data sourced from ClinicalTrials.gov (NCT01151098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.