Back to resultsSafety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients
Primary Purpose
Gastroesophageal Reflux Disease (GERD)
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Esomeprazole (Nexium)
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD)
Eligibility Criteria
Inclusion Criteria: Provision of signed written informed consent from the patient's parent/guardian, and assent from the patient prior to conducting of any study-related procedures. Patients must be male or female between the age of 12 and 17 years, inclusive. Patients must have a clinical diagnosis of GERD made by the investigator based on any of the following factors: history, physical examination, review of systems, laboratory test results, or information from diagnostic testing. Exclusion Criteria: Patients who have used a PPI within 14 days prior to randomization, including over-the-counter Prilosec®. Patients who have used any prescription or over-the-counter treatment for symptoms of gastroesophageal reflux disease (GERD), such as Histamine 2 Receptor Antagonists (H2RA) or prokinetics, within 3 days prior to randomization. Antacids may be used, except for those containing bismuth. Patients with a known hypersensitivity, allergy, or intolerance to any component of esomeprazole or omeprazole.
Sites / Locations
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Outcomes
Primary Outcome Measures
To evaluate safety & how tolerable a once daily treatment with esomeprazole is in pediatric & adolescent patients
12 to 17 years of age, inclusive, with clinically diagnosed Gastroesophageal Reflux Disease (G
Secondary Outcome Measures
To evaluate the clinical outcome of once daily treatment with esomeprazole in relieving gastroesophageal reflux disease (GERD)-associated signs & symptoms in pediatric & adolescent patients 12 to 17 years of age
- Assessment of changes from baseline in daily patient symptom assessment as reported by the patient.
- Assessment of changes from baseline in Physician Global Assessment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00241501
Brief Title
Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease (GERD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
140 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Esomeprazole (Nexium)
Primary Outcome Measure Information:
Title
To evaluate safety & how tolerable a once daily treatment with esomeprazole is in pediatric & adolescent patients
Title
12 to 17 years of age, inclusive, with clinically diagnosed Gastroesophageal Reflux Disease (G
Secondary Outcome Measure Information:
Title
To evaluate the clinical outcome of once daily treatment with esomeprazole in relieving gastroesophageal reflux disease (GERD)-associated signs & symptoms in pediatric & adolescent patients 12 to 17 years of age
Title
- Assessment of changes from baseline in daily patient symptom assessment as reported by the patient.
Title
- Assessment of changes from baseline in Physician Global Assessment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of signed written informed consent from the patient's parent/guardian, and assent from the patient prior to conducting of any study-related procedures.
Patients must be male or female between the age of 12 and 17 years, inclusive.
Patients must have a clinical diagnosis of GERD made by the investigator based on any of the following factors: history, physical examination, review of systems, laboratory test results, or information from diagnostic testing.
Exclusion Criteria:
Patients who have used a PPI within 14 days prior to randomization, including over-the-counter Prilosec®.
Patients who have used any prescription or over-the-counter treatment for symptoms of gastroesophageal reflux disease (GERD), such as Histamine 2 Receptor Antagonists (H2RA) or prokinetics, within 3 days prior to randomization. Antacids may be used, except for those containing bismuth.
Patients with a known hypersensitivity, allergy, or intolerance to any component of esomeprazole or omeprazole.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Nexium Medical Sciences Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
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Research Site
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Phoenix
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Arizona
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United States
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Little Rock
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Arkansas
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United States
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Wilmington
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Delaware
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United States
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Orlando
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Florida
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United States
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Atlanta
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Georgia
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United States
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Park Ridge
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Illinois
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United States
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Indianapolis
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Indiana
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United States
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Iowa City
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Iowa
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United States
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Shreveport
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Louisiana
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United States
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Boston
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Massachusetts
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United States
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Waltham
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Massachusetts
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United States
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Detroit
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Michigan
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United States
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Plymouth
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Minnesota
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United States
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St Paul
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Minnesota
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United States
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Jackson
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Mississippi
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United States
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Binghamton
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New York
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United States
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Bronx
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New York
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United States
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Brooklyn
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New York
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United States
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Buffalo
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New York
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United States
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Johnson City
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New York
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United States
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New Hyde Park
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New York
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United States
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Winston-Salem
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North Carolina
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United States
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Cleveland
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Ohio
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United States
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Dayton
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Ohio
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United States
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Philadelphia
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Pennsylvania
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United States
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Chattanooga
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Tennessee
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United States
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Burlington
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Vermont
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United States
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Norfolk
State/Province
Virginia
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United States
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City
Mount Pearl
State/Province
Newfoundland and Labrador
Country
Canada
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Halifax
State/Province
Nova Scotia
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Canada
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Hamilton
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Ontario
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Canada
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Oakville
State/Province
Ontario
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Canada
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Scarborough
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Ontario
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Canada
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Sudbury
State/Province
Ontario
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Canada
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Parkdale
State/Province
Prince Edward Island
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Canada
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Lille
Country
France
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Paris
Country
France
Facility Name
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Tours
Country
France
Facility Name
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Genova
State/Province
GE
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
19922626
Citation
Gunasekaran T, Tolia V, Colletti RB, Gold BD, Traxler B, Illueca M, Crawley JA. Effects of esomeprazole treatment for gastroesophageal reflux disease on quality of life in 12- to 17-year-old adolescents: an international health outcomes study. BMC Gastroenterol. 2009 Nov 18;9:84. doi: 10.1186/1471-230X-9-84.
Results Reference
derived
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Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients
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