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NCT00362609 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD
A Phase 3 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 59
- Enrollment target
NCT00362609: Completed Phase 3 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
NCT00362609 is a Phase 3 study that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 59 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00362609, a Phase 3 study, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 59 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.
Primary Outcome
Samples were divided between 2 groups for each dose: Group A at baseline, 2, 8, 18 hours; Group B at baseline, 1, 4, 12 hours to reduce the number of blood draws per infant. The variance of oral bioavailability was assessed to determine if further PK assessment was appropriate. It would be considered highly variable if the square root of the sum of the standard deviation squares of the area under the concentration-time curves from time zero to the time of the last quantifiable concentration (AUC
Interventions
- DRUG pantoprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2006-07 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
What the finished NCT00362609 record still lists
NCT00362609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which pantoprazole is the first listed.
NCT00362609 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00362609 about?
NCT00362609 is a clinical study titled "Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD". The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.
What is the current status of trial NCT00362609?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 59 participants. The study started on 2006-07. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00362609?
The interventions under investigation include: pantoprazole (DRUG).
Who is sponsoring clinical trial NCT00362609?
This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00362609's enrollment target sits among peer trials
59 1824th of 2000 higher than 176 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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