Back to resultsMesalazine Oral Suspension in Active Eosinophilic Esophagitis
Primary Purpose
Eosinophilic Esophagitis
Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Mesalamine Oral Product
Sponsored by
About this trial
This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring Esophageal dysfunction, esophageal inflammation
Eligibility Criteria
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
Sites / Locations
- Universitätsspital Zürich
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mesalamine treatment
Arm Description
Treatment of patient with mesalamine oral suspension
Outcomes
Primary Outcome Measures
Proportion of patients with histological remission
Assessment of remission of histological signs of EoE
Secondary Outcome Measures
Proportion of patients with histological response
Assessment of improvement of histological signs of EoE
Proportion of patients with improvement of symptoms
Clinical symptoms will be assessed via patient reported outcome measures.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05488405
Brief Title
Mesalazine Oral Suspension in Active Eosinophilic Esophagitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
July 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Falk Pharma GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pilot study to assess a mesalazine oral suspension in active eosinophilic esophagitis
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
Esophageal dysfunction, esophageal inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mesalamine treatment
Arm Type
Experimental
Arm Description
Treatment of patient with mesalamine oral suspension
Intervention Type
Drug
Intervention Name(s)
Mesalamine Oral Product
Other Intervention Name(s)
5-ASA
Intervention Description
Mesalamine oral suspension for oral use
Primary Outcome Measure Information:
Title
Proportion of patients with histological remission
Description
Assessment of remission of histological signs of EoE
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients with histological response
Description
Assessment of improvement of histological signs of EoE
Time Frame
4 weeks
Title
Proportion of patients with improvement of symptoms
Description
Clinical symptoms will be assessed via patient reported outcome measures.
Time Frame
4 weeks
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Biedermann, PD Dr. med.
Organizational Affiliation
UniversitätsSpital Zürich Klinik für Gastroenterologie und Hepatologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mesalazine Oral Suspension in Active Eosinophilic Esophagitis
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