MedTrace Logo

Intravenous (IV) Pantoprazole for Gastroesophageal Reflux Disease (GERD) in Neonates and Infants

NCT00744419 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-12-03

No results posted yet for this study

Summary

The purpose of this study is to determine how the body uses and eliminates pantoprazole, a drug used to treat GERD. This is a pharmacokinetic (PK) study. PK is a measure of how much drug is in the blood and how long it takes to leave the body. It is hypothesized that younger infants will need a lower dose than older children to achieve the same PK measurement.

The results of this study will be used to determine the best dose of the drug to use in each age group. Pantoprazole is a drug used to decrease acid production. The use of pantoprazole has not been approved for use in children. Pantoprazole is approved for use of acid-related and stomach disorders in adults.

Conditions

  • Gastroesophageal Reflux

Interventions

DRUG

pantoprazole

Intravenous pantoprazole will be administered daiy for 6 (+/- 1 day). The first 6 subjects in each age group will receive low dose \[0.4 mg/kg (\< 44 wks PMA) or 0.8 mg/kg (44 wks to \< 1 yr)\] and the last 6 subjects in each age group will receive high dose \[0.8 mg/kg(\< 44 wks PMA) or 1.6 mg/kg(44 wks to \< 1 yr)\]

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • University of Louisville

    lead OTHER

Principal Investigators

  • Angela M Jeffries, MD · University of Louisville

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
28 Weeks
Max Age
11 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00744419 on ClinicalTrials.gov