Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic Esophagitis
NCT02873468 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116
Last updated 2023-02-24
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.
Conditions
- Eosinophilic Esophagitis
Interventions
- DRUG
-
Florence 30 μg/mL
10 mL, oral, twice a day.
- DRUG
-
Florence 60 μg/mL
10 mL, oral, twice a day.
- DRUG
-
Florence 90 μg/mL
10 mL, oral, twice a day.
- OTHER
-
Placebo
10 mL, oral, twice a day.
Sponsors & Collaborators
-
EMS
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-19
- Primary Completion
- 2025-07-31
- Completion
- 2025-11-30
Countries
- Brazil
Study Locations
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