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

PHASE3CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

September 30, 2011

Study Completion Date

September 30, 2011

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

Trial Locations (1)

78744

Austin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT01389284 - Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium | Biotech Hunter | Biotech Hunter