Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
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.
Timeline
- Start
- 2015-02-24
- Primary completion
- 2015-03-19
- Completion
- 2015-03-19
Outcome
Met primary endpoint
Stopped (Business): “Business decision”
registry analysis (other test); Buprenorphine 0.5 mg TID vs Placebo; p = 0.012; LS Mean Difference 104.973 (95% CI 25.13 to 184.81); ANCOVA NCT02310581 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 0.5 mg | Other |
| Subject | Buprenorphine | Other / unclassified | 1 mg | Other |
Indications
No indication recorded.