NCT05488405

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

February 9, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2023

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

August 3, 2022

Last Update Submit

September 6, 2023

Conditions

Eosinophilic Esophagitis

Keywords

Esophageal dysfunction, esophageal inflammation

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with histological remission

    Assessment of remission of histological signs of EoE

    4 weeks

Secondary Outcomes (2)

  • Proportion of patients with histological response

    4 weeks

  • Proportion of patients with improvement of symptoms

    4 weeks

Study Arms (1)

Mesalamine treatment

EXPERIMENTAL

Treatment of patient with mesalamine oral suspension

Drug: Mesalamine Oral Product

Interventions

Mesalamine Oral ProductDRUG

Mesalamine oral suspension for oral use

Also known as: 5-ASA
Mesalamine treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Eosinophilic EsophagitisEsophageal DiseasesEsophagitis

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Luc Biedermann, PD Dr. med.

    UniversitätsSpital Zürich Klinik für Gastroenterologie und Hepatologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2022

First Posted

August 4, 2022

Study Start

February 9, 2023

Primary Completion

June 30, 2023

Study Completion

July 20, 2023

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)