Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Treatment-Withdrawal Study of the Efficacy and Safety of Pantoprazole Sodium Enteric-Coated Granules in Infants (1 Through 11 Months) With Symptomatic GERD.
Study Start Date
Primary Completion Date
Study Completion Date
Resource links provided by the National Library of Medicine
Number of Patients Withdrawn From Study Due to Lack of Efficacy. [ Time Frame: 4 weeks double-blind ]
Lack of efficacy defined as 1 or more of the following occurring during the double blind treatment-withdrawal phase: significant worsening of gastroesophageal reflux disease (GERD) symptoms frequency, a diagnostic test (e.g., endoscopy) demonstrating worsening of esophagitis, maximal antacid intake for ≥ 7 continuous days, or severe GERD symptoms based on physician's judgment.
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Ages Eligible for Study:
up to 11 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
known history of upper GI anatomic disorders
history of acute life-threatening medical conditions
clinically significant medical conditions or laboratory abnormalities