NCT02310581

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 for the Treatment of Moderate to Severe Pain

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: INSYS Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group, placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of Buprenorphine Sublingual (under the tongue) Spray and/or matching placebo in participants with moderate to severe postoperative pain after bunionectomy. The study will comprise 4 periods: the Screening Period, the Surgical Period, the Treatment Period, and the Follow-up Period. Participants will be admitted to the study site on the morning of the scheduled surgery, will remain at the study site until postoperative Day 3 (a total of 3 nights at the study site), and will return for the Follow-up Visit 5 to 9 days after surgery.

Conditions

• Post-operative Pain

Interventions

Type	Name	Description
DRUG	Buprenorphine Sublingual Spray	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: 2015-02-24
• Primary completion: 2015-03-19
• Completion: 2015-03-19
• First posted: 2014-12-08
• Last updated: 2017-08-09
• Results posted: 2017-08-09

Locations

3 sites across 1 country: United States