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Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)

NCT00992589 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2013-05-22

Study results available
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Summary

The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with placebo in the treatment of gastrointestinal esophageal reflux disease (GERD) in infants 1 to 11 months of age.

Conditions

  • Gastroesophageal Reflux

Interventions

DRUG

Rabeprazole sodium 5 mg

Rabeprazole Sodium 5 mg capsules once daily in the morning.

DRUG

Rabeprazole sodium 10 mg

Rabeprazole Sodium 10 mg capsules once daily in the morning.

DRUG

Placebo

Matching placebo capsules once daily in the morning.

Sponsors & Collaborators

  • Eisai Inc.

    collaborator INDUSTRY

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
11 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States
  • Australia
  • Belgium
  • Bulgaria
  • Denmark
  • Hungary
  • Israel
  • Netherlands
  • Poland
  • South Africa

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00992589 on ClinicalTrials.gov