Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain

Completed · Phase 3 · Has a placebo group

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT02634788

Run by

INSYS Therapeutics Inc

People needed

322

Starts

2016-01-29

Expected to finish

2016-06-24

Last updated by the study team

2017-08-14

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
• Willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
• Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

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

• Arizona Research Center — Phoenix, Arizona, United States
• Anaheim Clinical Trials — Anaheim, California, United States
• Chesapeake Research Group — Pasadena, Maryland, United States
• Jean Brown Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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