OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension

• Status: Completed
• Trial end date: 2014-10-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a clinical trial to test an experimental drug for the treatment of Eosinophilic Esophagitis (EoE)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Budesonide

Criteria

Inclusion Criteria:

• Males and Females, age 11-40

• Histologic evidence of EoE

• History of clinical symptoms of EoE including dysphagia

• Willing to continue with dietary, environmental or medical therapy

• Ability to read and understand english

• Written Consent

Exclusion Criteria:

• Any Medical condition that may compromise the safety of the subjects or interfere with the signs and symptoms of EoE

• Use of immunomodulatory therapy

• Current use of swallowed corticosteroids

• Esophageal strictures,varices or upper GI bleed

• Other current diseases of the GI tract

• Current viral infection or immunodeficiency condition

• Pregnancy

• Hypersensitivity to budesonide

• History of non compliance