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NCT05488405 Clinical Trial

Mesalazine Oral Suspension in Active Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

Official title:
Open-label, Monocentric Phase IIa Pilot Study Evaluating the Efficacy and Tolerability of a 4-week Treatment With Mesalazine Oral Suspension in Patients With Active Eosinophilic Esophagitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05488405
Other study ID # SAV-1/EEA
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 9, 2023
Est. completion date July 20, 2023

Study information
Verified date September 2023
Source Dr. Falk Pharma GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date July 20, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Mesalamine Oral Product
Mesalamine oral suspension for oral use

Locations
Country Name City State
Switzerland Universitätsspital Zürich Zürich

Sponsors (1)
Lead Sponsor Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients with histological remission Assessment of remission of histological signs of EoE 4 weeks
Secondary Proportion of patients with histological response Assessment of improvement of histological signs of EoE 4 weeks
Secondary Proportion of patients with improvement of symptoms Clinical symptoms will be assessed via patient reported outcome measures. 4 weeks
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