At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Open Label, Multiple-Dose, Comparator, Parallel-Group, Safety and Tolerance Study of Buprenorphine Sublingual Spray (0.5 mg TID) Versus Standard of Care Post-Operative Narcotic Therapy for the Treatment of Post-Operative Pain
In Brief
A Phase 2 clinical trial evaluating Buprenorphine Sublingual Spray, Morphine, and 2 other interventions for Pain, Postoperative. Completed, enrolled 100 participants across 2 sites.
Detailed Summary
This study will evaluate the safety and tolerability based on the incidence of adverse experiences of buprenorphine sublingual spray (0.5 milligrams \[mg\] three times daily \[TID\]) compared with standard post-operative narcotic therapy in participants with postoperative pain. Standard post-operative narcotic therapy is defined as morphine intravenous (IV) injection (4 mg TID) followed by oxycodone hydrochloride tablet (10 mg TID).
Study Details
Timeline
Interventions
0.5 mg Sublingual Spray
4 mg Intravenous Injection
10 mg tablet
4 mg oral disintegrating tablet (ODT) or IV injection given at the investigator's discretion for nausea