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: | June 2012 |
End Date: | October 2012 |
Contact: | Paul D Brittain, MPH |
Email: | paul.brittain@premier-research.com |
Phone: | 512-852-6917 |
A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Indomethacin Nanoformulation 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
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