Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
41 participants
INTERVENTIONAL
2005-08-31
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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pantoprazole for approximately 9 weeks.
Eligibility Criteria
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Inclusion Criteria
* Weight must be equal to or over 8.3 kg; for subjects 6 years or greater, weight must be equal to or under 25 kg
Exclusion Criteria
* Subjects 6-11 years old unable to swallow tablets
1 Year
11 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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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
Orange, California, United States
San Diego, California, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Miami, Florida, United States
Pensacola, Florida, United States
Park Ridge, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Brockton, Massachusetts, United States
Detroit, Michigan, United States
Flint, Michigan, United States
Jackson, Mississippi, United States
Kansas City, Missouri, United States
New York, New York, United States
Cincinnati, Ohio, United States
Memphis, Tennessee, United States
Temple, Texas, United States
Salt Lake City, Utah, United States
Milwaukee, Wisconsin, United States
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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B1791059
Identifier Type: -
Identifier Source: secondary_id
3001B3-334
Identifier Type: -
Identifier Source: org_study_id