Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients
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.
1 other identifier
interventional
140
4 countries
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2004
Shorter than P25 for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 18, 2005
CompletedFirst Posted
Study publicly available on registry
October 19, 2005
CompletedNovember 19, 2010
November 1, 2010
October 18, 2005
November 18, 2010
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (40)
Research Site
Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Wilmington, Delaware, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
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Park Ridge, Illinois, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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Shreveport, Louisiana, United States
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Boston, Massachusetts, United States
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Waltham, Massachusetts, United States
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Detroit, Michigan, United States
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Plymouth, Minnesota, United States
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Saint Paul, Minnesota, United States
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Jackson, Mississippi, United States
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Binghamton, New York, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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Johnson City, New York, United States
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New Hyde Park, New York, United States
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The Bronx, New York, United States
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Winston-Salem, North Carolina, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Burlington, Vermont, United States
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Norfolk, Virginia, United States
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Mount Pearl, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Greater Sudbury, Ontario, Canada
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Hamilton, Ontario, Canada
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Oakville, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Parkdale, Prince Edward Island, Canada
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Lille, France
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Paris, France
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Tours, France
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Genova, GE, Italy
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Roma, Roma, Italy
Related Publications (1)
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.
PMID: 19922626DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Nexium Medical Sciences Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 18, 2005
First Posted
October 19, 2005
Study Start
February 1, 2004
Study Completion
April 1, 2005
Last Updated
November 19, 2010
Record last verified: 2010-11