Study of Indomethacin Capsules to Treat Pain Following Bunionectomy



Status:Completed
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:February 2012
End Date:July 2012
Contact:Paul D Brittain, MPH
Email:paul.brittain@premier-research.com
Phone:512-852-6917

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A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Indomethacin [Test] Capsules for the Treatment of Acute Postoperative Pain After Bunionectomy


The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and
effective for the treatment of postoperative bunionectomy pain.


Inclusion Criteria:

- Patient is male or female between 18 and 65 years of age

- For women of child-bearing potential: a woman who is not pregnant and not nursing,
and who is practicing an acceptable method of birth control

- Has undergone primary, unilateral, first metatarsal bunionectomy with no additional
collateral procedures

- Patient must be willing to stay at the study site ≥ 72 hours

Exclusion Criteria:

- Patient has hypersensitivity, allergy, or clinically significant intolerance to any
medications to be used in the study, or related drugs

- Patient has a current disease or history of a disease that will impact the study or
the patient's well-being

- Patient has used or intends to use any of the medications that are prohibited by the
protocol

- Patient has a history of drug or alcohol abuse or dependence, or patient has a
positive urine drug screen or alcohol breathalyzer test

- Patient has taken another investigational drug within 30 days prior to screening
We found this trial at
4
sites
Salt Lake City, Utah 84107
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8028 Ritchie Highway
Pasadena, Maryland 21122
443-557-0374
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Pasadena, MD
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Austin, Texas 78705
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Austin, TX
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Phoenix, Arizona 85027
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Phoenix, AZ
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