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Esomeprazole for Treatment of GERD in Pediatric Patients

Primary Purpose

Gastroesophageal Reflux Disease (GERD), Erosive Esophagitis, Non-erosive Esophagitis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Esomeprazole (Nexium)
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD)

Eligibility Criteria

1 Year - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

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Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
September 27, 2005
Last Updated
November 18, 2010
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00228527
Brief Title
Esomeprazole for Treatment of GERD in Pediatric Patients
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease (GERD), Erosive Esophagitis, Non-erosive Esophagitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Esomeprazole (Nexium)
Primary Outcome Measure Information:
Title
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.
Title
The primary outcome variables include assessment of changes from baseline in medical history, physical examination, clinical laboratory evaluations, and adverse events.
Secondary Outcome Measure Information:
Title
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.
Title
The secondary objectives include:
Title
- Assessment of changes from baseline in daily patient symptom assessment as reported by parent/guardian.
Title
- Assessment of changes from baseline in Physician's Global Assessment
Title
- Assessment of endoscopic healing of erosive esophagitis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Research Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Wilmington
State/Province
Delaware
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Park Ridge
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Troy
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Jackson
State/Province
Mississippi
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Research Site
City
Morristown
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Research Site
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Research Site
City
West Islip
State/Province
New York
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Burlington
State/Province
Vermont
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Brussels (Jette)
Country
Belgium
Facility Name
Research Site
City
Brussels (Laeken)
Country
Belgium
Facility Name
Research Site
City
Brussels (Woluwé-St-Lambert)
Country
Belgium
Facility Name
Research Site
City
Brussels
Country
Belgium
Facility Name
Research Site
City
Leuven
Country
Belgium
Facility Name
Research Site
City
Lille
Country
France
Facility Name
Research Site
City
Paris
Country
France
Facility Name
Research Site
City
Tours
Country
France
Facility Name
Research Site
City
Genova
State/Province
GE
Country
Italy
Facility Name
Research Site
City
Parma
State/Province
PR
Country
Italy
Facility Name
Research Site
City
Roma
State/Province
RM
Country
Italy
Facility Name
Research Site
City
Napoli
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
26422096
Citation
Tolia V, Gilger MA, Barker PN, Illueca M. Healing of Erosive Esophagitis and Improvement of Symptoms of Gastroesophageal Reflux Disease After Esomeprazole Treatment in Children 12 to 36 Months Old. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S31-6. doi: 10.1097/MPG.0b013e3181ddcf11.
Results Reference
derived
PubMed Identifier
26422095
Citation
Tolia V, Youssef NN, Gilger MA, Traxler B, Illueca M. Esomeprazole for the Treatment of Erosive Esophagitis in Children: An International, Multicenter, Randomized, Parallel-Group, Double-Blind (for Dose) Study. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S24-30. doi: 10.1097/01.mpg.0000469419.29000.94.
Results Reference
derived
PubMed Identifier
26121348
Citation
Tolia V, Gilger MA, Barker PN, Illueca M. Healing of Erosive Esophagitis and Improvement of Symptoms of Gastroesophageal Reflux Disease After Esomeprazole Treatment in Children 12 to 36 Months Old. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S31-6. doi: 10.1097/MPG.0b013e3181ddcf11.
Results Reference
derived
PubMed Identifier
26121347
Citation
Tolia V, Youssef NN, Gilger MA, Traxler B, Illueca M. Esomeprazole for the Treatment of Erosive Esophagitis in Children: An International, Multicenter, Randomized, Parallel-Group, Double-Blind (for Dose) Study. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S24-30. doi: 10.1097/01.mpg.0000469419.29000.94.
Results Reference
derived
PubMed Identifier
20706150
Citation
Tolia V, Gilger MA, Barker PN, Illueca M. Healing of erosive esophagitis and improvement of symptoms of gastroesophageal reflux disease after esomeprazole treatment in children 12 to 36 months old. J Pediatr Gastroenterol Nutr. 2010 Nov;51(5):593-8. doi: 10.1097/MPG.0b013e3181ddcf11.
Results Reference
derived
PubMed Identifier
20540767
Citation
Tolia V, Youssef NN, Gilger MA, Traxler B, Illueca M. Esomeprazole for the treatment of erosive esophagitis in children: an international, multicenter, randomized, parallel-group, double-blind (for dose) study. BMC Pediatr. 2010 Jun 11;10:41. doi: 10.1186/1471-2431-10-41.
Results Reference
derived
PubMed Identifier
18493207
Citation
Gilger MA, Tolia V, Vandenplas Y, Youssef NN, Traxler B, Illueca M. Safety and tolerability of esomeprazole in children with gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr. 2008 May;46(5):524-33. doi: 10.1097/MPG.0b013e318176b2cb.
Results Reference
derived

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Esomeprazole for Treatment of GERD in Pediatric Patients

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