Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborator: Nycomed
• Treatments: Pantoprazole

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.