Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
NCT ID: NCT00259012
Last Updated: 2010-05-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
67 participants
INTERVENTIONAL
2005-11-30
2008-03-31
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
NONE
Study Groups
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Low dose
pantoprazole sodium enteric-coated spheroid suspension
pediatric suspension taken daily x 7 days
High dose
pantoprazole sodium enteric-coated spheroid suspension
pediatric suspension taken daily x 7 days
Interventions
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pantoprazole sodium enteric-coated spheroid suspension
pediatric suspension taken daily x 7 days
Eligibility Criteria
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Inclusion Criteria
* Presumptive diagnosis of GERD
* Weight greater than 2.5 kg but less than 15 kg
Exclusion Criteria
* Clinically significant medical or surgical abnormalities
1 Month
11 Months
ALL
No
Sponsors
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Nycomed
INDUSTRY
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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Little Rock, Arkansas, United States
Loma Linda, California, United States
San Diego, California, United States
Washington D.C., District of Columbia, United States
Miami, Florida, United States
Pensacola, Florida, United States
Chicago, Illinois, United States
Park Ridge, Illinois, United States
Louisville, Kentucky, United States
Shreveport, Louisiana, United States
Jackson, Mississippi, United States
Kansas City, Missouri, United States
New York, New York, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Temple, Texas, United States
Brisbane, , Australia
Antwerp, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Paris, , France
Aachen, , Germany
Osnabrück, , Germany
Brescia, , Italy
Naples, , Italy
Roma, , Italy
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Warsaw, , Poland
Zurich, , Switzerland
Countries
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References
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Tammara BK, Sullivan JE, Adcock KG, Kierkus J, Giblin J, Rath N, Meng X, Maguire MK, Comer GM, Ward RM. Randomized, open-label, multicentre pharmacokinetic studies of two dose levels of pantoprazole granules in infants and children aged 1 month through <6 years with gastro-oesophageal reflux disease. Clin Pharmacokinet. 2011 Aug;50(8):541-50. doi: 10.2165/11591900-000000000-00000.
Other Identifiers
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3001B3-333, 3001B3-335
Identifier Type: -
Identifier Source: org_study_id
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