NCT03254459

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: INSYS Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Buprenorphine Sublingual Spray	0.5 mg Sublingual Spray
DRUG	Morphine	4 mg Intravenous Injection
DRUG	Oxycodone Hydrochloride	10 mg tablet
DRUG	Zofran	4 mg oral disintegrating tablet (ODT) or IV injection given at the investigator's discretion for nausea

Timeline

• Start date: 2017-09-12
• Primary completion: 2017-11-13
• Completion: 2017-11-13
• First posted: 2017-08-18
• Last updated: 2018-10-29
• Results posted: 2018-10-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study