Mesalazine Oral Suspension in Active Eosinophilic Esophagitis

Dr. Falk Pharma GmbH5 enrolled

Overview

Pilot study to assess a mesalazine oral suspension in active eosinophilic esophagitis

This is an open-label, monocentric exploratory phase IIa pilot study, which serves to evaluate the efficacy, safety, and tolerability of treatment with mesalazine oral suspension for the treatment of active eosinophilic esophagitis (EoE).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eosinophilic Esophagitis

Interventions

Mesalamine Oral ProductDRUG

Mesalamine oral suspension for oral use

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed informed consent * Male or female patients, 18 to 75 years of age * Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria * Negative pregnancy test in females of childbearing potential Exclusion Criteria: * Other causes for esophageal eosinophilia * Clinical and endoscopic signs of gastroesophageal reflux disease (GERD) * Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection \[candida esophagitis\]) * Any known or suspicion for relevant infectious diseases associated with clinical signs, * Known intolerance/hypersensitivity/resistance to the IMP or excipients or drugs of similar chemical structure or pharmacological profile * Existing or intended pregnancy or breast-feeding

Locations (1)

Universitätsspital Zürich

Zurich, Switzerland

Outcomes

Primary Outcomes

Proportion of patients with histological remission

Assessment of remission of histological signs of EoE

Time frame: 4 weeks

Secondary Outcomes

Proportion of patients with histological response

Assessment of improvement of histological signs of EoE

Time frame: 4 weeks

Proportion of patients with improvement of symptoms

Clinical symptoms will be assessed via patient reported outcome measures.

Time frame: 4 weeks

Data from ClinicalTrials.gov

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