Testing Florence oral suspension for treating eosinophilic esophagitis in adults

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

This study is testing different doses of a new oral medication to see if it can help adults with eosinophilic esophagitis feel better by reducing inflammation in their esophagus.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ems (Industry-sponsored)
• Locations: 1 site (Campinas, São Paulo)
• Trial ID: NCT02873468 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of three different doses of Florence oral suspension in adults diagnosed with eosinophilic esophagitis. Participants will receive either the active medication at varying concentrations or a placebo, with the primary focus on measuring changes in eosinophilic infiltration through esophageal biopsies. The study aims to determine the optimal dosage that effectively reduces eosinophilic inflammation in the esophagus. It is a Phase 2 interventional trial, indicating a focus on assessing the treatment's effectiveness and safety.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with eosinophilic esophagitis and exhibit specific symptoms and biopsy results.

Not a fit: Patients with other gastrointestinal disorders or those who have undergone gastroesophageal surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of eosinophilic esophagitis, leading to better symptom control and quality of life for patients.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in treating eosinophilic esophagitis with other therapies, indicating potential for success.

Eligibility 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.

Where this trial is running

Campinas, São Paulo

• Allergisa — Campinas, São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Arthur M Kummer, MD

Conditions Eosinophilic Esophagitis