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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02873468
Recruitment Status : Not yet recruiting
First Posted : August 19, 2016
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
EMS

Brief 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.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Drug: Florence 30 μg/mL Drug: Florence 60 μg/mL Drug: Florence 90 μg/mL Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Florence 30 Drug: Florence 30 μg/mL
10 mL, oral, twice a day.
Other Name: EMS oral suspension

Experimental: Florence 60 Drug: Florence 60 μg/mL
10 mL, oral, twice a day.
Other Name: EMS oral suspension

Experimental: Florence 90 Drug: Florence 90 μg/mL
10 mL, oral, twice a day.
Other Name: EMS oral suspension

Placebo Comparator: Placebo Other: Placebo
10 mL, oral, twice a day.
Other Name: Florence placebo




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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873468


Contacts
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Contact: Monalisa FB Oliveira, MD +551938879851 pesquisa.clinica@ems.com.br

Sponsors and Collaborators
EMS

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Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT02873468     History of Changes
Other Study ID Numbers: EMS0718 - FLORENCE
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Eosinophilic Esophagitis
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases