Phase 3/Safety & Efficacy of Esomeprazole in Infants

PHASE3CompletedINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

June 30, 2008

Study Completion Date

June 30, 2008

Conditions
Gastroesophageal Reflux Disease (GERD)
Interventions
DRUG

Open Label Run In Esomeprazole

Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)

DRUG

Double Blind Esomeprazole

Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)

DRUG

Double Blind Placebo

Double Blind Placebo

Trial Locations (25)

Unknown

Research Site, Phoenix

Research Site, Atlanta

Research Site, Park Ridge

Research Site, Louisville

Research Site, Marrero

Research Site, Newton

Research Site, Southfield

Research Site, Las Vegas

Research Site, Brooklyn

Research Site, New York

Research Site, Akron

Research Site, Dayton

Research Site, Chattanooga

Research Site, Roanoke

Research Site, Lille

Research Site, Paris

Research Site, Bochum

Research Site, Greifswald

Research Site, Nurberg

Research Site, Potsdam

Research Site, Wuppertal

Research Site, Bialystok

Research Site, Krakow

Research Site, Warsaw

Research Site, Wroclaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY