Study of Diclofenac Capsules to Treat Pain Following Bunionectomy

Launched by IROKO PHARMACEUTICALS, LLC · Oct 27, 2011

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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