Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
NCT ID: NCT00365300
Last Updated: 2010-05-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
129 participants
INTERVENTIONAL
2006-09-30
2007-11-30
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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Pantoprazole
pantoprazole
Placebo
Placebo
Interventions
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pantoprazole
Placebo
Eligibility Criteria
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Inclusion Criteria
* clinical diagnosis of GERD
* weight greater than 2.5 kg and less than or equal to 15 kg
Exclusion Criteria
* history of acute life-threatening medical conditions
* clinically significant medical conditions or laboratory abnormalities
28 Days
11 Months
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Wyeth
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Mobile, Alabama, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Oakland, California, United States
Orange, California, United States
Washington D.C., District of Columbia, United States
Miami, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Tampa, Florida, United States
Augusta, Georgia, United States
Peoria, Illinois, United States
Bardstown, Kentucky, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Flint, Michigan, United States
Jackson, Mississippi, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Camden, New Jersey, United States
Mays Landing, New Jersey, United States
Morristown, New Jersey, United States
Brooklyn, New York, United States
Buffalo, New York, United States
Valhalla, New York, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Bethlehem, Pennsylvania, United States
Memphis, Tennessee, United States
Temple, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Huntington, West Virginia, United States
Morgantown, West Virginia, United States
Madison, Wisconsin, United States
Countries
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Other Identifiers
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3001B3-329
Identifier Type: -
Identifier Source: org_study_id
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