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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 March 2023
• Main ID: NCT02873468
• Date of registration: 16/08/2016
• Prospective Registration: Yes
• Primary sponsor: EMS
• Public title: Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic Esophagitis
• Scientific title: Randomized, Double-blind, Multicentric, Parallel, National, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic Esophagitis
• Date of first enrolment: April 19, 2021
• Target sample size: 116
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02873468
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Brazil

Contacts

• Name: Marcello I Rabello, MD

• Name: Arthur M Kummer, MD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis

Intervention(s)

Drug: Florence 90 µg/mL

Other: Placebo

Drug: Florence 60 µg/mL

Drug: Florence 30 µg/mL

Primary Outcome(s)

Proportion of participants presenting a histological response, defined as the presence of = 6 eosinophils/high-power field, at the end of treatment. [Time Frame: 100 days]

Secondary Outcome(s)

Incidence and severity of adverse events recorded during the study. [Time Frame: 170 days]

Secondary ID(s)

EMS0718 - FLORENCE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors