The Use of Lansoprazole to Treat Infants With Symptoms of Gastroesophageal Reflux

PHASE3CompletedINTERVENTIONAL
Enrollment

162

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

May 31, 2007

Study Completion Date

May 31, 2007

Conditions
Gastroesophageal Reflux Disease
Interventions
DRUG

Lansoprazole microgranules suspension

"Lansoprazole microgranules 0.2-0.3 mg/kg/day suspension, orally, once daily for up to 28 days for infants less than 10 weeks;~Lansoprazole microgranules 1.0-1.5 mg/kg/day suspension, orally, once daily for up to 28 days for infants greater than 10 weeks."

DRUG

Placebo

Lansoprazole placebo-matching suspension, orally, once daily for up to 28 days.

Trial Locations (17)

Unknown

Tampa

Park Ridge

Shreveport

Flint

Omaha

Buffalo

Cincinnati

Youngstown

Vienna

Bialystok

Katowice

Krakow

Lodz

Lublin

Rzeszów

Warsaw

Wroclaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY