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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02873468
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	EMS
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Brazil
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Esophagitis

Arms & Interventions

Arms

Experimental: Florence 30

Experimental: Florence 60

Experimental: Florence 90

Placebo Comparator: Placebo

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.

Contact a Trial Team

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International Sites

Allergisa, Campinas, São Paulo, Brazil

Status

Recruiting

Address

Allergisa

Campinas, São Paulo,

Site Contact

Marcello I Rabello, MD

[email protected]

+551938879851

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