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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: Completed Phase 1 study, sponsored by University of Louisville.
NCT00744419 is a Phase 1 study that has completed, run by University of Louisville. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-05 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
What the finished NCT00744419 record still lists
NCT00744419 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which pantoprazole is the first listed.
NCT00744419 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00744419's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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