Mesalazine Oral Suspension in Active Eosinophilic Esophagitis

NCT ID: NCT05488405

Last Updated: 2023-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-09

Study Completion Date

2023-07-20

Brief Summary

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

Detailed Description

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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).

Conditions

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Eosinophilic Esophagitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mesalamine treatment

Treatment of patient with mesalamine oral suspension

Group Type EXPERIMENTAL

Mesalamine Oral Product

Intervention Type DRUG

Mesalamine oral suspension for oral use

Interventions

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Mesalamine Oral Product

Mesalamine oral suspension for oral use

Intervention Type DRUG

Other Intervention Names

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5-ASA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Falk Pharma GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luc Biedermann, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

UniversitätsSpital Zürich Klinik für Gastroenterologie und Hepatologie

Locations

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Universitätsspital Zürich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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SAV-1/EEA

Identifier Type: -

Identifier Source: org_study_id

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