Study of Indomethacin Capsules to Treat Pain Following Bunionectomy

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