Dose-Ranging Study of Oral Viscous Budesonide in Pediatrics With Eosinophilic Esophagitis

NCT00762073 PHASE2 COMPLETED Results posted

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.

Details

Lead sponsor	Shire
Phase	PHASE2
Status	COMPLETED
Enrolment	82
Start date	Thu Jan 08 2009 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Apr 02 2010 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Eosinophilic Esophagitis (EoE)

Interventions

• budesonide
• placebo

Countries

United States