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Completed Phase 3 Interventional

Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients

ClinicalTrials.gov ID: NCT00241501

Public ClinicalTrials.gov record NCT00241501. 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 Sep 2, 2026, 8:01 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 of Once Daily Esomeprazole for the Treatment of Clinically Diagnosed Gastroesophageal Reflux Disease (GERD) in Pediatric and Adolescent Patients 12 to 17 Years of Age, Inclusive.

Brief summary

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

This study is a phase III, multi-centre, randomized, double-blind study to assess the safety and tolerability of once daily treatment with esomeprazole 20 or 40 mg in pediatric and adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed GERD. The treatment period will be up to 8 weeks.

Study identification

NCT ID
NCT00241501
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
AstraZeneca
Industry
Enrollment
140 participants

Conditions and interventions

Eligibility (public fields only)

Age range
12 Years to 17 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
Jan 31, 2004
Primary completion
Not listed
Completion
Mar 31, 2005
Last update posted
Nov 18, 2010

2004 – 2005

United States locations

U.S. sites
28
U.S. states
20
U.S. cities
28
Facility City State ZIP Site status
Research Site Phoenix Arizona
Research Site Little Rock Arkansas
Research Site Wilmington Delaware
Research Site Orlando Florida
Research Site Atlanta Georgia
Research Site Park Ridge Illinois
Research Site Indianapolis Indiana
Research Site Iowa City Iowa
Research Site Shreveport Louisiana
Research Site Boston Massachusetts
Research Site Waltham Massachusetts
Research Site Detroit Michigan
Research Site Plymouth Minnesota
Research Site Saint Paul Minnesota
Research Site Jackson Mississippi
Research Site Binghamton New York
Research Site Brooklyn New York
Research Site Buffalo New York
Research Site Johnson City New York
Research Site New Hyde Park New York
Research Site The Bronx New York
Research Site Winston-Salem North Carolina
Research Site Cleveland Ohio
Research Site Dayton Ohio
Research Site Philadelphia Pennsylvania
Research Site Chattanooga Tennessee
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 NCT00241501, 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 18, 2010 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00241501 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →