Study of Indomethacin Capsules to Treat Pain Following Bunionectomy

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Iroko Pharmaceuticals, LLC
• Treatments: Indomethacin

Criteria

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