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 |
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.
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
1085 N Harbor Blvd
Anaheim, California 92801
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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