Conditions: Post-operative Pain
Keywords: Bunionectomy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days. arm 2: Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days. arm 3: Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days. arm 4: Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.

Interventions: intervention 1: Buprenorphine Sublingual Spray intervention 2: Placebo
Intervention descriptions: intervention 1: Buprenorphine sublingual spray delivered via single 100 μL spray intervention 2: Placebo-matching buprenorphine sublingual spray delivered via single 100 μL spray

Protocol document: