Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine

PHASE4CompletedINTERVENTIONAL
Enrollment

162

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

February 29, 2008

Study Completion Date

February 29, 2008

Conditions
Sleep
Interventions
DRUG

Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg

Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

DRUG

Naproxen Sodium 440 mg (BAYH6689)

Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.

DRUG

Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg

One dose of naproxen sodium 220 mg plus diphenhydramine 50 mg

DRUG

Naproxen Sodium 220 mg (BAYH6689)

Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.

DRUG

DPH 50mg

Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.

DRUG

Ibuprofen 400 mg / Diphenhydramine citrate 76 mg

Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.

Trial Locations (1)

84124

Salt Lake City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY