Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
Status:
Terminated
Trial end date:
2015-03-19
Target enrollment:
Participant gender:
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.