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Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium

NCT01389284 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2015-08-25

Study results available
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Summary

The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with postsurgical dental pain.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Naproxen Sodium ER (BAYH6689)

660 mg Naproxen Sodium extended release tablet, orally administered once daily for 24 hours

DRUG

Naproxen Sodium IR (Aleve, BAYH6689)

220 mg Naproxen Sodium instant release tablet, orally administered 3 times daily (TID) for 24 hours

DRUG

Naproxen Sodium ER Placebo

Matching placebo of 660 mg Naproxen Sodium ER for 24 hours

DRUG

Naproxen Sodium IR Placebo

Matching placebo of 220 mg Naproxen Sodium IR (Aleve) for 24 hours

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT01389284 on ClinicalTrials.gov