Mesalazine Oral Suspension in Active Eosinophilic Esophagitis

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Falk Pharma GmbH
• Treatments: Mesalamine

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