Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic Esophagitis

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of three doses of Florence oral suspension on changes of eosinophilic infiltration in esophageal biopsies.

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

Details

• Lead Sponsor: EMS
• Treatments: Fluticasone

Criteria

Inclusion Criteria:

• Signed consent;

• Participants aged 18 years or more;

• Participants diagnosed with eosinophilic esophagitis, defined as:

1. Presence of symptoms of esophageal dysfunction intermittently or continuously during previous week to the screening visit;

2. Eosinophilic esophageal inflammation with ≥ 15 eosinophils/high-power field, in the screening endoscopy;

3. Exclusion of other causes of esophageal eosinophilia.

Exclusion Criteria:

• Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;

• Participants with a stricture on endoscopy that prevents passage of the endoscope;

• History of alcohol abuse or drug use;

• Use of concomitant therapies for any reason that may affect the assessment;

• History of gastroesophageal surgery;

• History of the abnormal gastrointestinal disorder;

• Another disorder that causes esophageal eosinophilia;

• Pregnancy or risk of pregnancy and lactating patients;

• Participants with known allergy, contraindication or hypersensitivity to the components of the medicine used in the clinical trial;

• Participation in clinical trial in the year prior to this study.