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Study of Naproxen Capsules to Treat Dental Pain

NCT01229228 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2012-05-22

Study results available
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Summary

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

Conditions

  • Dental Pain

Interventions

DRUG

Naproxen Test

200-mg single dose

DRUG

Naproxen Test

400-mg (2 x 200-mg)

DRUG

Naprosyn

single dose

DRUG

Naprosyn

single dose

DRUG

Placebo

single dose

Sponsors & Collaborators

  • Iroko Pharmaceuticals, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01229228 on ClinicalTrials.gov