Dose-Ranging Study of Oral Viscous Budesonide in Pediatrics With Eosinophilic Esophagitis
Status:
Completed
Trial end date:
2010-04-02
Target enrollment:
Participant gender:
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.