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Completed
NCT00300755
Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
Conditions: Gastroesophageal Reflux
Sex: All
Ages: 1 Year – 5 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 60
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Location: Mobile Alabama
Summary
To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.
Eligibility Criteria
Inclusion Criteria:
* Ability to undergo endoscopy with required biopsy
* Ages 1 through 5 years
* Endoscopically confirmed GERD by positive endoscopic evidence of reflux related esophagitis or positive histologic evidence of esophagitis consistent with GERD Other inclusions apply.
Exclusion Criteria:
* History or presence of upper gastrointestinal anatomic or motor disorders
* Known current or active cow's milk allergy
* Malignancy
* Other exclusions apply.
Source: ClinicalTrials.gov (NCT00300755). StuddyBuddy aggregates publicly available trial information.