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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02873468
Other study ID # EMS0718 - FLORENCE
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 19, 2021
Est. completion date November 2025

Study information

Verified date February 2023
Source EMS
Contact Arthur M Kummer, MD
Phone +551938879851
Email pesquisa.clinica@ems.com.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 116
Est. completion date November 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Florence 30 µg/mL
10 mL, oral, twice a day.
Florence 60 µg/mL
10 mL, oral, twice a day.
Florence 90 µg/mL
10 mL, oral, twice a day.
Other:
Placebo
10 mL, oral, twice a day.

Locations

Country Name City State
Brazil Allergisa Campinas São Paulo

Sponsors (1)

Lead Sponsor Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Incidence and severity of adverse events recorded during the study. 170 days
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