At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 322 enrolled
Drug / intervention
Buprenorphine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Buprenorphine and Placebo for Pain. Completed, enrolled 322 participants across 4 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartJan 2016
Primary CompletionJun 2016
TodayJul 2026
First PostedDec 18, 2015
Enrollment StartJan 29, 2016
Primary CompletionJun 24, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.5 years ago
Interventions
Buprenorphinedrug
Buprenorphine sublingual spray delivered via single 100 μL spray
Placebodrug
Placebo-matching buprenorphine sublingual spray delivered via single 100 μL spray