Study Evaluating Pantoprazole in Children With GERD
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux
Intervention: pantoprazole for approximately 9 weeks. (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Summary
The purpose of this study is to characterize the PK profile, safety and tolerability of
single and multiple doses of pantoprazole in children aged 1 through 11 years with
endoscopically proven GERD.
Clinical Details
Official title: A Multicenter, Randomized, Open Label, Single, and Multiple Dose Study of the Safety and Pharmacokinetics of 2 Dose Levels of Pantoprazole Sodium in Children Aged 1 Through 11 Years With Endoscopically Proven GERD.
Study design: Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics Study
Primary outcome: Characterization of the PK profile of single and multiple doses of pantoprazole.
Secondary outcome: Assessment of safety and tolerability of pantoprazole and assessment of growth parameters
Eligibility
Minimum age: 1 Year.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Endoscopically proven GERD diagnosed within 6 months before study entry.
- 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:
- History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption,
Eosinophilic esophagitis
- Subjects 6-11 years old unable to swallow tablets
Locations and Contacts
Little Rock, Arkansas 72205, United States
San Diego, California 92103, United States
Orange, California 92868, United States
Washington, District of Columbia 20010, United States
Gainesville, Florida 32610, United States
Miami, Florida 33101, United States
Pensacola, Florida 32504, United States
Park Ridge, Illinois 60068, United States
Indianapolis, Indiana 46202, United States
Louisville, Kentucky 40202, United States
Brockton, Massachusetts 02302, United States
Boston, Massachusetts 02115, United States
Boston, Massachusetts 02114, United States
Detroit, Michigan 48201, United States
Flint, Michigan 48503, United States
Jackson, Mississippi 39216, United States
Kansas City, Missouri 64108, United States
New York, New York 10032, United States
Cincinnati, Ohio 45229, United States
Memphis, Tennessee 38105, United States
Temple, Texas 76508, United States
Salt Lake City, Utah 84108, United States
Milwaukee, Wisconsin 53226, United States
Additional Information
Starting date: August 2005
Ending date: November 2007
Last updated: December 18, 2007
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