Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
98 participants
INTERVENTIONAL
2007-04-30
2008-06-30
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
QUADRUPLE
Study Groups
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Open Label Esomeprazole
This is an open label, run-in phase. All patients received Esomeprazole.
Open Label Run In Esomeprazole
Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)
Double Blind Esomeprazole
This is the double blind withdrawal phase. Patients are randomized to active drug or placebo.
Double Blind Esomeprazole
Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)
Double Blind Placebo
This is the double blind withdrawal phase. Patients are randomized to active drug or placebo.
Double Blind Placebo
Double Blind Placebo
Interventions
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Open Label Run In Esomeprazole
Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)
Double Blind Esomeprazole
Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)
Double Blind Placebo
Double Blind Placebo
Eligibility Criteria
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Inclusion Criteria
* patients must have symptoms at study entry and have a clinical diagnosis of suspected GERD, symptomatic GERD, or GERD proven by a test called an endoscopy, a test using a long tube inserted in the body for diagnostic exams
Exclusion Criteria
* patients with a history of acute life-threatening event
1 Month
11 Months
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Marta Ilueca
Role: STUDY_DIRECTOR
AstraZeneca
Jennifer Heckman
Role: STUDY_DIRECTOR
AstraZeneca
Jill McGuinn
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Phoenix, Arizona, United States
Research Site
Atlanta, Georgia, United States
Research Site
Park Ridge, Illinois, United States
Research Site
Louisville, Kentucky, United States
Research Site
Marrero, Louisiana, United States
Research Site
Newton, Massachusetts, United States
Research Site
Southfield, Michigan, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Brooklyn, New York, United States
Research Site
New York, New York, United States
Research Site
Akron, Ohio, United States
Research Site
Dayton, Ohio, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Roanoke, Virginia, United States
Research Site
Lille, , France
Research Site
Paris, , France
Research Site
Bochum, , Germany
Research Site
Greifswald, , Germany
Research Site
Nurberg, , Germany
Research Site
Potsdam, , Germany
Research Site
Wuppertal, , Germany
Research Site
Bialystok, , Poland
Research Site
Krakow, , Poland
Research Site
Warsaw, , Poland
Research Site
Wroclaw, , Poland
Countries
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References
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Winter H, Gunasekaran T, Tolia V, Gottrand F, Barker PN, Illueca M. Esomeprazole for the Treatment of GERD in Infants Ages 1-11 Months. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S9-15. doi: 10.1097/MPG.0b013e3182496b35.
Winter H, Gunasekaran T, Tolia V, Gottrand F, Barker PN, Illueca M. Esomeprazole for the Treatment of GERD in Infants Ages 1-11 Months. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S9-15. doi: 10.1097/MPG.0b013e3182496b35.
Winter H, Gunasekaran T, Tolia V, Gottrand F, Barker PN, Illueca M. Esomeprazole for the treatment of GERD in infants ages 1-11 months. J Pediatr Gastroenterol Nutr. 2012 Jul;55(1):14-20. doi: 10.1097/MPG.0b013e3182496b35.
Related Links
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Other Identifiers
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D9614C00096
Identifier Type: -
Identifier Source: org_study_id
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