Study Evaluating Pantoprazole in Adolescents 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 (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 characterize the PK profile of single and multiple doses of
pantoprazole in adolescents aged 12 to 16 years with Gastroesophageal Reflux Disease (GERD).
Clinical Details
Official title: A Multicenter, Randomized, Open-Label, Single And Multiple Dose Study Of The Pharmacokinetics And Safety of Two Dose Levels of Pantoprazole Sodium Tablets In Adolescents Aged 12 Through 16 Years With A Clinical Daignosis Of 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: Assess the safety and tolerability of pantoprazole.
Eligibility
Minimum age: 12 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 12-16 years old
- clinical diagnosis of GERD
- ability to swallow tablets
Exclusion Criteria:
- GI or malabsorption disorders
- chronic use of warfarin
- positive pregnancy test
Locations and Contacts
Additional Information
Starting date: January 2007
Ending date: August 2007
Last updated: December 7, 2007
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