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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Florence 30 | Experimental |
| |
| Florence 60 | Experimental |
| |
| Florence 90 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Florence 30 μg/mL | Drug | 10 mL, oral, twice a day. |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants presenting a histological response, defined as the presence of ≤ 6 eosinophils/high-power field, at the end of treatment. | 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events recorded during the study. | 170 days |
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Inclusion Criteria:
Signed consent;
Participants aged 18 years or more;
Participants diagnosed with eosinophilic esophagitis, defined as:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arthur M Kummer, MD | Contact | +551938879851 | pesquisa.clinica@ems.com.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergisa | Recruiting | Campinas | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Florence 60 μg/mL | Drug | 10 mL, oral, twice a day. |
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| Florence 90 μg/mL | Drug | 10 mL, oral, twice a day. |
|
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| Placebo | Other | 10 mL, oral, twice a day. |
|
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| D005759 |
| Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |