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

Phase 3

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Drug: Placebo; Drug: pantoprazole

• Registration Number: NCT00365300
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-16
• Study First Submitted QC: 2006-08-16
• Study First Posted: 2006-08-17
• Study Start: 2006-09
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Results First Submitted: 2009-11-30
• Results First Submitted QC: 2009-11-30
• Results First Posted: 2010-01-07
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-26
• Last Update Posted: 2010-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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

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Exclusion Criteria

• known history of upper GI anatomic disorders
• history of acute life-threatening medical conditions
• clinically significant medical conditions or laboratory abnormalities

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Pantoprazole	pantoprazole	-

Primary Outcome Measures

Name	Time	Method
Number of Patients Withdrawn From Study Due to Lack of Efficacy.	4 weeks double-blind	Lack of efficacy defined as 1 or more of the following occurring during the double blind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.