Overview

Study of Diclofenac 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 Diclofenac [Test] Capsules are safe and effective for the treatment of bunionectomy pain.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Iroko Pharmaceuticals, LLC
Treatments:
Celecoxib
Diclofenac
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