Study of Naproxen Capsules to Treat Dental Pain

Iroko Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Dental Pain

Treatments: Drug: Naprosyn; Drug: Naproxen Test; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01229228

NAP2-08-03

Details and patient eligibility

About

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

Enrollment: 254 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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254 participants in 5 patient groups, including a placebo group

Naproxen Test (lower dose)

Experimental group

Description:

200-mg

Treatment:

Drug: Naproxen Test

Drug: Naproxen Test

Naproxen Test (upper dose)

Experimental group

Description:

400-mg (2 x 200-mg)

Treatment:

Drug: Naproxen Test

Drug: Naproxen Test

Naprosyn 250 mg

Active Comparator group

Treatment:

Drug: Naprosyn

Drug: Naprosyn

Naprosyn 500 mg

Active Comparator group

Treatment:

Drug: Naprosyn

Drug: Naprosyn

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo