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Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD

NCT00259012 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2010-05-07

Study results available
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Summary

The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.

Conditions

  • Gastroesophageal Reflux

Interventions

DRUG

pantoprazole sodium enteric-coated spheroid suspension

pediatric suspension taken daily x 7 days

Sponsors & Collaborators

  • Nycomed

    collaborator INDUSTRY

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
11 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States
  • Australia
  • Belgium
  • France
  • Germany
  • Italy
  • Poland
  • Switzerland

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 NCT00259012 on ClinicalTrials.gov