drugset / Trial / NCT03254459

Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain

NCT03254459

Phase 2 Completed 100 enrolled INSYS Therapeutics Inc
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2017-09-12
Primary completion
2017-11-13
Completion
2017-11-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 0.5 mg Other
Comparator Morphine Other / unclassified 4 mg Intravenous
Comparator Oxycodone Other / unclassified 10 mg Oral
Background Ondansetron Other / unclassified 4 mg Oral

Indications

No indication recorded.