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



Status:Recruiting
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:December 2015
End Date:June 2016

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A Phase 3, Randomized, Double Blind, Multiple Dose, Parallel Group, Placebo Controlled Study of Buprenorphine Sublingual Spray (0.5 mg TID, 0.25 mg TID, and 0.125 mg TID) for the Treatment of Moderate to Severe Pain

The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine
Sublingual Spray compared with placebo in subjects with postoperative pain after
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 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
5
sites
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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8028 Ritchie Highway
Pasadena, Maryland 21122
443-557-0374
Phone: 410-761-0118
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1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
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Houston, Texas 77004
Phone: 713-367-8548
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Phoenix, Arizona 85023
Phone: 602-773-3027
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