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NCT00468559 · ClinicalTrials.gov registry record · Phase 3
Phase 3/Safety & Efficacy of Esomeprazole in Infants
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 98
- Enrollment target
NCT00468559 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 98 participants.
The verdict
NCT00468559, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 98 participants
- Enrollment target
Study Summary
The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research study consists of a screening, open-label, and double-blind treatment withdrawal phase. The screening phase ensures the patient eligibility. No study medication is dispensed during the screening phase. During the open-label phase, patients are administered esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase, the patients are administered either his/her open-label dose or placebo. Double-blind means neither the physician, parent, or patient will know if patient is taking esomeprazole or placebo. The patient will have an equal chance of receiving esomeprazole or placebo.
Interventions
- DRUG Open Label Run In Esomeprazole
- DRUG Double Blind Esomeprazole
- DRUG Double Blind Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2007-04 |
| Est. Completion | 2008-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00468559
The ClinicalTrials.gov registry entry for NCT00468559 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Open Label Run In Esomeprazole is the first listed.
NCT00468559 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00468559 about?
NCT00468559 is a clinical study titled "Phase 3/Safety & Efficacy of Esomeprazole in Infants". The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research study consists of a screening, open-label, and double-blind treatment withdrawal phase. The screening...
What is the current status of trial NCT00468559?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 98 participants. The study started on 2007-04. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00468559?
The interventions under investigation include: Open Label Run In Esomeprazole (DRUG), Double Blind Esomeprazole (DRUG), Double Blind Placebo (DRUG).
Who is sponsoring clinical trial NCT00468559?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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