Conditions: Eosinophilic Esophagitis (EoE)
Keywords: EoE
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 93
Healthy volunteers: no

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

Detailed 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.

Arms:
arm 1: Taken once or twice daily for up to 40 weeks arm 2: Taken once or twice daily for 20 weeks

Interventions: intervention 1: Oral Budesonide Suspension (MB-9) intervention 2: Placebo
Intervention descriptions: intervention 1: OBS suspension to be taken bid over a 16 week course of double blind therapy and OBS suspension to be taken qd to bid during a 24 week optional open label extension period intervention 2: None

Protocol document: