Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Pain

In brief

The primary objective of this trial is to evaluate analgesic efficacy of Fentanyl Sublingual Spray compared with placebo in participants with postoperative pain after a bunionectomy.

Key facts

Study ID

NCT02915978

Run by

INSYS Therapeutics Inc

People needed

45

Starts

2016-12-01

Expected to finish

2017-02-10

Last updated by the study team

2018-02-14

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 to 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

Full record on ClinicalTrials.gov

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