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NCT00762073 · ClinicalTrials.gov registry record · Phase 2
Dose-Ranging Study of Oral Viscous Budesonide in Pediatrics With Eosinophilic Esophagitis
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
NCT00762073: Completed Phase 2 study, sponsored by Shire.
NCT00762073 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 82 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00762073, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
Study Summary
This is a randomized, placebo-controlled, parallel-arm, dose-ranging study in subjects with eosinophilic esophagitis, 2-18 years of age. Eligible subjects will be randomized into one of four treatment groups. The Treatment Period will be 12 weeks during which subjects will visit the clinic at study weeks 0 (Baseline Visit), 2, 4, 8 and 12 (Final Treatment Evaluation) for clinical symptom assessment and safety evaluation (including adverse events and vital signs). All study treatments (active drug and placebo) will be administered orally twice daily during the Treatment Period, once in the morning after breakfast and once in the evening at bedtime.
Primary Outcome
Response was defined as a ≥50% reduction from baseline in the eosinophilic esophagitis (EoE) clinical symptom score (CSS) and a reduction in peak eosinophil count to ≤6/high power field (light microscopy) from esophageal biopsies collected at the final evaluation. The EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynopha
Interventions
- DRUG placebo
- DRUG budesonide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2009-01-08 |
| Est. Completion | 2010-04-02 |
| Phase | Phase 2 |
What the finished NCT00762073 record still lists
NCT00762073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00762073 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00762073 about?
NCT00762073 is a clinical study titled "Dose-Ranging Study of Oral Viscous Budesonide in Pediatrics With Eosinophilic Esophagitis". This is a randomized, placebo-controlled, parallel-arm, dose-ranging study in subjects with eosinophilic esophagitis, 2-18 years of age. Eligible subjects will be randomized into one of four treatment groups. The Treatment Period will be 12 weeks during which subjects will visit the clinic at study ...
What is the current status of trial NCT00762073?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2009-01-08. Estimated completion is 2010-04-02.
What interventions are being tested in trial NCT00762073?
The interventions under investigation include: placebo (DRUG), budesonide (DRUG).
Who is sponsoring clinical trial NCT00762073?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00762073's enrollment target sits among peer trials
82 830th of 2000 higher than 1,167 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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