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NCT00744419 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by University of Louisville.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT00744419 is a Phase 1 study that has completed, run by University of Louisville. The registered enrollment target is 24 participants.

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The verdict

NCT00744419, a Phase 1 study, has completed, sponsored by University of Louisville.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

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.

Interventions

  • DRUG pantoprazole

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2009-05
Est. Completion 2012-04
Phase Phase 1

Sponsor

University of Louisville

217 total trials

What the Registry Record Tells You About NCT00744419

The ClinicalTrials.gov registry entry for NCT00744419 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which pantoprazole is the first listed.

NCT00744419 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00744419 about?

NCT00744419 is a clinical study titled "Intravenous (IV) Pantoprazole for Gastroesophageal Reflux Disease (GERD) in Neonates and Infants". 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 lowe...

What is the current status of trial NCT00744419?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2009-05. Estimated completion is 2012-04.

What interventions are being tested in trial NCT00744419?

The interventions under investigation include: pantoprazole (DRUG).

Who is sponsoring clinical trial NCT00744419?

This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.