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

NCT00300755 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-05-19

Study results available
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Summary

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

Conditions

  • Gastroesophageal Reflux

Interventions

DRUG

pantoprazole sodium enteric-coated spheroid

pediatric spheroids taken daily x 8 weeks

Sponsors & Collaborators

  • Nycomed

    collaborator INDUSTRY

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00300755 on ClinicalTrials.gov