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



Status:Completed
Conditions:Chronic Pain, Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 65
Updated:2/16/2018
Start Date:December 2016
End Date:February 10, 2017

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A Phase 2 Multicenter, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain

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.


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
We found this trial at
2
sites
Phoenix, Arizona 85023
Phone: 602-773-3027
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Phone: 714-774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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