Study of Naproxen Capsules to Treat Dental Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Dental Pain

In brief

The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe and effective for the treatment of dental pain.

Key facts

Study ID

NCT01229228

Run by

Iroko Pharmaceuticals, LLC

People needed

254

Starts

2010-10-01

Expected to finish

2011-04-01

Last updated by the study team

2012-05-22

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Premier Research Group Limited — Austin, Texas, United States

Full record on ClinicalTrials.gov

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