NCT02634788

Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain

A Phase 3, Randomized, Double Blind, Multiple Dose, Parallel Group, Placebo Controlled Study of Buprenorphine Sublingual Spray (0.5 mg TID, 0.25 mg TID, and 0.125 mg TID) for the Treatment of Moderate to Severe Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 322 (actual)
• Sponsor: INSYS Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine Sublingual (under the tongue) Spray compared with placebo in participants with postoperative pain after bunionectomy.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Buprenorphine	Buprenorphine sublingual spray delivered via single 100 μL spray
DRUG	Placebo	Placebo-matching buprenorphine sublingual spray delivered via single 100 μL spray

Timeline

• Start date: 2016-01-29
• Primary completion: 2016-06-24
• Completion: 2016-06-24
• First posted: 2015-12-18
• Last updated: 2017-08-14
• Results posted: 2017-08-14

Locations

4 sites across 1 country: United States