Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Post-operative Pain

In brief

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.

Key facts

Study ID

NCT02310581

Run by

INSYS Therapeutics Inc

People needed

40

Starts

2015-02-24

Expected to finish

2015-03-19

Last updated by the study team

2017-08-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets protocol-specified criteria for qualification and contraception
• Is able to speak and understand the language in which the study is being conducted, is able to understand the procedures and study requirements and has voluntarily signed and dated an informed consent form approved by the Institutional Review Board before the conduct of any study procedure
• Is willing and able to comply with study requirements (including diet, alcohol, and smoking restrictions), complete the pain evaluations, remain at the study site for three days, and return for follow up between 7 and 9 days after surgery.

You may not qualify if…

• History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
• Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
• the safety or well-being of the participant or study staff
• the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
• the analysis of results

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Pasadena, Maryland, United States
• Study site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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