Phase 3
Completed N=290
Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase
Source: ClinicalTrials.gov NCT01141283 ↗Enrolled (actual)
290
Serious AEs
2.1%
Results posted
Sep 2010
Primary outcomePrimary: The Number of Participants With Adverse Events as a Measure of Safety and Tolerability — 0; 6; 202 participants
Summary
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
0; 6; 202 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with moderate to severe osteoarthritic (OA) pain who completed all visits of the double-blind phase on study drug, or who discontinued study drug due to lack of therapeutic effect in the double-blind phase, but still completed all visits of the double-blind phase off study drug, are eligible to enroll in the extension phase.
Exclusion Criteria
- Excluded from the study are subjects who ingest > 2500 mg/day acetaminophen as part of their current stable nonopioid analgesic regimen.
- 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.
Data sourced from ClinicalTrials.gov (NCT01141283). 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.