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Completed Phase 4 Interventional

Esomeprazole for Treatment of GERD in Pediatric Patients

ClinicalTrials.gov ID: NCT00228527

Public ClinicalTrials.gov record NCT00228527. 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 21, 2026, 1:13 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 Phase III, Multicentre, Randomized, Double-blind Parallel-group Study to Evaluate the Safety and Clinical Outcome of Once Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients 1 to 11 Years of Age, Inclusive.

Brief summary

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

To look at the safety and improvement in symptoms of a once a day dosing of esomeprazole in children 1 to 11 years old with inflammation of their esophagus or food pipe ("esophagitis") caused by gastroesophageal reflux disease (GERD) and diagnosed by endoscopy. To verify the healing of the esophageal inflammation if the endoscopy reveals cuts in the lining of the food pipe. To collect information that will describe the psychological, social, and economic effects on the primary caregiver of raising children ages 1 to 5 years old with GERD.

Study identification

NCT ID
NCT00228527
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
AstraZeneca
Industry
Enrollment
100 participants

Conditions and interventions

Eligibility (public fields only)

Age range
1 Year to 11 Years
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 2004 (Type not available)
Primary completion
Not listed
Completion
Oct 2005 (Actual)
Last update posted
Nov 19, 2010

2004 – 2005

United States locations

U.S. sites
24
U.S. states
18
U.S. cities
24
Facility City State ZIP Site status
Research Site Mobile Alabama — —
Research Site Phoenix Arizona — —
Research Site Wilmington Delaware — —
Research Site Orlando Florida — —
Research Site Chicago Illinois — —
Research Site Park Ridge Illinois — —
Research Site Boston Massachusetts — —
Research Site Detroit Michigan — —
Research Site Troy Michigan — —
Research Site Jackson Mississippi — —
Research Site St Louis Missouri — —
Research Site Omaha Nebraska — —
Research Site Morristown New Jersey — —
Research Site Brooklyn New York — —
Research Site Buffalo New York — —
Research Site West Islip New York — —
Research Site Columbus Ohio — —
Research Site Hershey Pennsylvania — —
Research Site Philadelphia Pennsylvania — —
Research Site Chattanooga Tennessee — —
Research Site Dallas Texas — —
Research Site Houston Texas — —
Research Site Burlington Vermont — —
Research Site Norfolk 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 12 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00228527, 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 Nov 19, 2010 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00228527 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →