Status:
COMPLETED
Study of Naproxen Capsules to Treat Dental Pain
Lead Sponsor:
Iroko Pharmaceuticals, LLC
Conditions:
Dental Pain
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe and effective for the treatment of dental pain.
Eligibility Criteria
Inclusion
- Patient is male or female between 18 and 50 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
- Patient requires extraction of 2 or more third molars
- Patient must be willing to stay at the study site overnight
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 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT01229228
Start Date
October 1 2010
End Date
April 1 2011
Last Update
May 22 2012
Active Locations (1)
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1
Premier Research Group Limited
Austin, Texas, United States, 78705