Esomeprazole for Treatment of GERD in Pediatric Patients

November 18, 2010 updated by: AstraZeneca

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Research Site
      • Brussels (Jette), Belgium
        • Research Site
      • Brussels (Laeken), Belgium
        • Research Site
      • Brussels (Woluwé-St-Lambert), Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
  • France
      • Lille, France
        • Research Site
      • Paris, France
        • Research Site
      • Tours, France
        • Research Site
  • Italy
      • Napoli, Italy
        • Research Site
    • GE
      • Genova, GE, Italy
        • Research Site
    • PR
      • Parma, PR, Italy
        • Research Site
    • RM
      • Roma, RM, Italy
        • Research Site
  • United States
    • Alabama
      • Mobile, Alabama, United States
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States
        • Research Site
    • Delaware
      • Wilmington, Delaware, United States
        • Research Site
    • Florida
      • Orlando, Florida, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
      • Park Ridge, Illinois, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
    • Michigan
      • Detroit, Michigan, United States
        • Research Site
      • Troy, Michigan, United States
        • Research Site
    • Mississippi
      • Jackson, Mississippi, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States
        • Research Site
    • New Jersey
      • Morristown, New Jersey, United States
        • Research Site
    • New York
      • Brooklyn, New York, United States
        • Research Site
      • Buffalo, New York, United States
        • Research Site
      • West Islip, New York, United States
        • Research Site
    • Ohio
      • Columbus, Ohio, United States
        • Research Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Research Site
    • Texas
      • Dallas, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
    • Vermont
      • Burlington, Vermont, United States
        • Research Site
    • Virginia
      • Norfolk, Virginia, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients' parents/guardians must provide written informed consent prior to the execution of any study-related procedures.
  • Patients who are able to comprehend their involvement in a clinical study, including risks and benefits, (typically ≥6 years of age) must have assent documented by study personnel prior to any study-related procedures.
  • Patients must be diagnosed with endoscopically proven GERD by the investigator during the screening period or have a previous (within 2 weeks prior to Visit 1) diagnosis of erosive esophagitis by endoscopy and are candidates for PPI therapy.

Exclusion Criteria:

  • Patients who have used a proton pump inhibitor within 14 days prior to randomization, including over-the-counter omeprazole.
  • Patients who have used any prescription or over-the-counter (OTC) treatment (other than proton pump inhibitors) for symptoms of GERD, such as histamine 2 receptor antagonists or prokinetics, within 72 hours prior to randomization.
  • Patients with a known hypersensitivity, allergy, or intolerance to any component of esomeprazole or omeprazole.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary objective of the study is to evaluate the safety of once daily treatment with esomeprazole in relieving GERD-associated symptoms in pediatric patients 1 to 11 years of age, inclusive.
The primary outcome variables include assessment of changes from baseline in medical history, physical examination, clinical laboratory evaluations, and adverse events.

Secondary Outcome Measures

Outcome Measure
The secondary objective of the study is to evaluate the clinical outcome of once daily treatment with esomeprazole in relieving GERD-associated signs and symptoms in pediatric patients 1 to 11 years of age, inclusive.
The secondary objectives include:
- Assessment of changes from baseline in daily patient symptom assessment as reported by parent/guardian.
- Assessment of changes from baseline in Physician's Global Assessment
- Assessment of endoscopic healing of erosive esophagitis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

September 27, 2005

First Submitted That Met QC Criteria

September 27, 2005

First Posted (Estimate)

September 29, 2005

Study Record Updates

Last Update Posted (Estimate)

November 19, 2010

Last Update Submitted That Met QC Criteria

November 18, 2010

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9614C00097

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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