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

• Status: Completed
• Trial end date: 2017-02-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: INSYS Therapeutics Inc
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

1. the safety or well-being of the participant or study staff;

2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);

3. the analysis of results