Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain

PHASE3CompletedINTERVENTIONAL
Enrollment

712

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

January 31, 2011

Study Completion Date

February 28, 2011

Conditions
Pain, Postoperative
Interventions
DRUG

Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111)

Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose

DRUG

Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)

Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose

DRUG

Naproxen sodium 440 mg (BAYH6689)

Participants received two Naproxen sodium 220 mg tablets orally, single dose

DRUG

DPH 50 mg

Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Trial Locations (2)

78744

Austin

84124

Salt Lake City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY