Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).

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

Details

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

Criteria

Inclusion Criteria:

• term or post term infants beyond the neonatal period of an age greater than 28 days but less than or equal to 11 months

• clinical diagnosis of GERD

• weight greater than 2.5 kg and less than or equal to 15 kg

Exclusion Criteria:

• known history of upper GI anatomic disorders

• history of acute life-threatening medical conditions

• clinically significant medical conditions or laboratory abnormalities