Eosinophilic Esophagitis
Conditions
Brief 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.
Interventions
DRUGFlorence 30 μg/mL
10 mL, oral, twice a day.
DRUGFlorence 60 μg/mL
10 mL, oral, twice a day.
DRUGFlorence 90 μg/mL
10 mL, oral, twice a day.
OTHERPlacebo
10 mL, oral, twice a day.
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants presenting a histological response, defined as the presence of ≤ 6 eosinophils/high-power field, at the end of treatment. | 100 days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events recorded during the study. | 170 days |
Countries
Brazil
Contacts
Primary ContactArthur M Kummer, MD
Outcome results
None listed