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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00992589

Public ClinicalTrials.gov record NCT00992589. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 8:26 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Withdrawal Study to Evaluate the Safety and Efficacy of Delayed Release Rabeprazole in 1- to 11-Month-Old Pediatric Subjects With Symptomatic/Gastroesophageal Erosive Reflux Disease (GERD)

Study identification

NCT ID
NCT00992589
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Industry
Enrollment
344 participants

Conditions and interventions

Interventions

  • Rabeprazole sodium 5 mg Drug
  • Rabeprazole sodium 10 mg Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
1 Month to 11 Months
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 31, 2009
Primary completion
Oct 31, 2011
Completion
Oct 31, 2011
Last update posted
May 21, 2013

2009 – 2011

United States locations

U.S. sites
43
U.S. states
26
U.S. cities
43
Facility City State ZIP Site status
Not listed Birmingham Alabama
Not listed Columbiana Alabama
Not listed Dothan Alabama
Not listed Huntsville Alabama
Not listed Mobile Alabama
Not listed Phoenix Arizona
Not listed Bentonville Arkansas
Not listed Orange California
Not listed Centennial Colorado
Not listed Thornton Colorado
Not listed Maitland Florida
Not listed Miami Florida
Not listed Augusta Georgia
Not listed Park Ridge Illinois
Not listed Indianapolis Indiana
Not listed Louisville Kentucky
Not listed Owensboro Kentucky
Not listed New Orleans Louisiana
Not listed Shreveport Louisiana
Not listed Boston Massachusetts
Not listed Worcester Massachusetts
Not listed Flint Michigan
Not listed Saint Paul Minnesota
Not listed Jackson Mississippi
Not listed Bridgeton Missouri
Not listed Mays Landing New Jersey
Not listed Valhalla New Jersey
Not listed Buffalo New York
Not listed The Bronx New York
Not listed Utica New York
Not listed Charlotte North Carolina
Not listed Toledo Ohio
Not listed Youngstown Ohio
Not listed Gresham Oregon
Not listed Hershey Pennsylvania
Not listed Chattanooga Tennessee
Not listed Kingsport Tennessee
Not listed Dallas Texas
Not listed Laredo Texas
Not listed San Antonio Texas
Not listed Tomball Texas
Not listed Fairfax Virginia
Not listed Huntington West Virginia

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 38 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00992589, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 21, 2013 · Synced Jul 22, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00992589 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →