Conditions: Eosinophilic Esophagitis (EoE)
Keywords: eosinophilic esophagitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 82
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: Low Dose Group arm 3: Medium Dose Group arm 4: High Dose Group

Interventions: intervention 1: budesonide intervention 2: placebo
Intervention descriptions: intervention 1: oral suspension intervention 2: oral suspension matching budesonide

Protocol document: