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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: Completed Phase 3 study, sponsored by AstraZeneca.
NCT00468559 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 98 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants discontinuing during the 4-week of randomized double-blind withdrawal phase that met the pre-set definition of symptom worsening criteria.
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 |
What the finished NCT00468559 record still lists
NCT00468559 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Open Label Run In Esomeprazole is the first listed.
NCT00468559 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00468559's enrollment target sits among peer trials
98 1714th of 2000 higher than 283 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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