A Study of Single and Multiple Doses of Rabeprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Months Old, Inclusive

PHASE1CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

February 29, 2012

Study Completion Date

February 29, 2012

Conditions
Gastroesophageal Reflux Disease (GERD)
Interventions
DRUG

Rabeprazole sodium 5 mg

Type= exact number, unit= mg, number= 5, format= bead suspension formulation, route= oral use. Rabeprazole sodium 0.5 mg/kg (using increments of 1 mg dose) once daily from Day 1 to Day 5; possible extension using 5 mg once daily up to 28 consecutive days.

DRUG

Rabeprazole sodium 10 mg

Type= exact number, unit= mg, number= 10, format= bead suspension formulation, route= oral use. Rabeprazole sodium 0.5 mg/kg (using increments of 1 mg dose) once daily from Day 1 to up to Day 14; possible extension using 10 mg once daily up to 28 consecutive days.

Trial Locations (20)

Unknown

Little Rock

Oakland

Washington D.C.

Maitland

Louisville

Jackson

Bridgeton

Long Branch

Greenville

Cleveland

Toledo

Youngstown

Houston

Antwerp

Brussels

São Paulo

Lublin

Warsaw

Barnsley

London

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY

NCT00747526 - A Study of Single and Multiple Doses of Rabeprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Months Old, Inclusive | Biotech Hunter | Biotech Hunter