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

Wyeth is now a wholly owned subsidiary of Pfizer129 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

129

Conditions

Gastroesophageal Reflux

Interventions

pantoprazoleDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 28 DaysMax age: 11 Months

Medical Language ↔ Plain English

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

Locations (38)

Outcomes

Primary Outcomes

Number of Patients Withdrawn From Study Due to Lack of Efficacy.

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.

Time frame: 4 weeks double-blind

Data from ClinicalTrials.gov

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Oakland, California, United States

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Orange, California, United States

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Washington D.C., District of Columbia, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Pensacola, Florida, United States

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Tampa, Florida, United States

...and 28 more locations