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NCT00747526 · ClinicalTrials.gov registry record · Phase 1
A Study of Single and Multiple Doses of Rabeprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Months Old, Inclusive
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT00747526 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 51 participants.
The verdict
NCT00747526, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time), pharmacodynamics (how the study medication affects the body) and safety of rabeprazole after single and multiple daily administration in infants between the ages of 1 and 11 months, inclusive, with Gastroesophageal Reflux Disease (GERD).
Interventions
- DRUG Rabeprazole sodium 5 mg
- DRUG Rabeprazole sodium 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2007-12 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00747526
The ClinicalTrials.gov registry entry for NCT00747526 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rabeprazole sodium 5 mg is the first listed.
NCT00747526 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00747526 about?
NCT00747526 is a clinical study titled "A Study of Single and Multiple Doses of Rabeprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Months Old, Inclusive". The purpose of the study is to evaluate the pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time), pharmacodynamics (how the study medication affects the body) and safety of rabeprazole after single and multiple daily admin...
What is the current status of trial NCT00747526?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2007-12. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00747526?
The interventions under investigation include: Rabeprazole sodium 5 mg (DRUG), Rabeprazole sodium 10 mg (DRUG).
Who is sponsoring clinical trial NCT00747526?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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