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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 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 82 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00762073
The ClinicalTrials.gov registry entry for NCT00762073 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00762073 reports 0 study locations.
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.
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