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Clinical trial

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

ID
Name
SAV-1/EEA
Description
Pilot study to assess a mesalazine oral suspension in active eosinophilic esophagitis
Trial arms
Trial start
2023-02-09
Estimated PCD
2023-06-30
Trial end
2023-07-20
Status
Completed
Phase
Early phase I
Treatment
Mesalamine Oral Product
Mesalamine oral suspension for oral use
Arms:
Mesalamine treatment
Other names:
5-ASA
Size
5
Primary endpoint
Proportion of patients with histological remission
4 weeks
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}
Updated at
2023-09-07

1 organization

1 product

1 indication

Organization
Dr. Falk Pharma
Product
Mesalamine
Indication
Eosinophilic Esophagitis