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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 Oct 22, 2026, 5:50 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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00992589
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
344 participants

Conditions and interventions

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
Nov 2009 (Type not available)
Primary completion
Nov 2011 (Actual)
Completion
Nov 2011 (Actual)
Last update posted
May 22, 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 22, 2013 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00992589 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →