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

Shire

Status and phase

Completed

Phase 2

Conditions

Eosinophilic Esophagitis (EoE)

Treatments

Drug: Placebo

Drug: Oral Budesonide Suspension (MB-9)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01642212

MPI-101-06

Details and patient eligibility

About

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

Full description

Eosinophilic Esophagitis (EoE) is an inflammatory disorder of the esophagus and is a recognized clinical entity. Symptoms include feeding problems, heartburn, regurgitation, vomiting, abdominal pain and food impaction. The symptoms of EoE may be similar to gastroesophageal reflux disease (GERD) but do not resolve with gastric acid suppression. EoE is defined histologically as the presence of > 15 intraepithelial eosinophils per high power fields on one or more esophageal biopsy specimens.

This Phase II study is comparing oral budesonide (OBS) to placebo to demonstrate that OBS induces a histologic response and a symptom response using a Dysphagia Symptom Questionnaire over a 16 week course of therapy.

Enrollment

93 patients

Sex

All

Ages

11 to 40 years old

Volunteers

No Healthy Volunteers

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