Safety Trial of Naproxen Sodium/ Diphenhydramine

PHASE3CompletedINTERVENTIONAL
Enrollment

326

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

July 31, 2011

Study Completion Date

July 31, 2011

Conditions
Pain
Interventions
DRUG

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

2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days

DRUG

Placebo

2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days

Trial Locations (19)

21075

Elkridge

29464

Mt. Pleasant

30281

Stockbridge

33028

Pembroke Pines

33143

South Miami

34741

Kissimmee

70006

Metairie

76135

Fort Worth

76904

San Angelo

78231

San Antonio

80922

Colorado Springs

84106

Salt Lake City

85203

Mesa

85224

Chandler

85381

Peoria

91730

Rancho Cucamonga

92801

Anaheim

95816

Sacramento

02886

Warwick

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY