Mesalazine Oral Suspension in Active Eosinophilic Esophagitis

September 6, 2023 updated by: Dr. Falk Pharma GmbH

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8091
        • Universitatsspital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mesalamine treatment
Treatment of patient with mesalamine oral suspension
Drug: Mesalamine Oral Product
Mesalamine oral suspension for oral use
Other Names:
  • 5-ASA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with histological remission
Time Frame: 4 weeks
Assessment of remission of histological signs of EoE
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with histological response
Time Frame: 4 weeks
Assessment of improvement of histological signs of EoE
4 weeks
Proportion of patients with improvement of symptoms
Time Frame: 4 weeks
Clinical symptoms will be assessed via patient reported outcome measures.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Falk Pharma GmbH

Investigators

  • Principal Investigator: Luc Biedermann, PD Dr. med., UniversitätsSpital Zürich Klinik für Gastroenterologie und Hepatologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2023

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

July 20, 2023

Study Registration Dates

First Submitted

August 3, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 4, 2022

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAV-1/EEA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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