Status:
COMPLETED
Study of Diclofenac Capsules to Treat Pain Following Bunionectomy
Lead Sponsor:
Iroko Pharmaceuticals, LLC
Conditions:
Other Acute Postoperative Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether Diclofenac \[Test\] Capsules are safe and effective for the treatment of bunionectomy pain.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
428 Patients enrolled
Trial Details
Trial ID
NCT01462435
Start Date
October 1 2011
End Date
August 1 2012
Last Update
February 4 2014
Active Locations (4)
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1
Premier Research Group Limited
Phoenix, Arizona, United States, 85027
2
Chesapeake Research Group, LLC
Pasadena, Maryland, United States, 21122
3
Premier Research Group Limited
Austin, Texas, United States, 78705
4
Premier Research Group Limited
Salt Lake City, Utah, United States, 84107