Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients
NCT ID: NCT00241501
Last Updated: 2010-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
140 participants
INTERVENTIONAL
2004-02-29
2005-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Esomeprazole (Nexium)
Eligibility Criteria
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Inclusion Criteria
* 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 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.
12 Years
17 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Nexium Medical Sciences Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Phoenix, Arizona, United States
Research Site
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
Countries
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References
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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.
Other Identifiers
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D9614C00098
Identifier Type: -
Identifier Source: org_study_id