Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shire
Age
2–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and female subjects between the ages of 2-18 years, inclusive
History of clinical symptoms of esophageal dysfunction intermittently or continuously
Histologic evidence of EoE with a peak eosinophil count of greater than or equal to 20 eosinophils per HPF, from two or more levels of the esophagus, within six weeks prior to the Baseline Visit
At the Baseline Visit, subjects must have symptoms with a total EoE Clinical Symptom Score of greater than or equal to 3
Willingness and ability to continue the dietary therapy, environmental therapy, and/or medical regimens (including gastric acid suppression, if any) in effect at the Screening Visit
Females of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin) prior to randomization into the study and sexually active subjects must agree to continue acceptable birth control measures throughout the duration of the study
Written informed consent (parent or legal guardian) and, as appropriate, subject assent
You may not be if
Current use of immunomodulatory therapy (or anticipated use within 12 weeks following the Baseline Visit)
Diagnosis of inflammatory bowel disease
Chronic viral infection or immunodeficiency condition (current)
Use of swallowed topical corticosteroids for EoE in the 1 month prior to the biopsy required for entrance to this study or at any time between the biopsy and the Baseline Visit
Use of systemic (oral or parenteral) corticosteroid within 1 month prior to the biopsy required for entrance to this study or at any time between the biopsy and the Baseline Visit
Morning plasma cortisol level below the lower limit of normal (per Central Laboratory reference range) at the Screening Visit
Upper gastrointestinal bleeding within 1 month prior to the Screening Visit or between the Screening Visit and Baseline Visit
Current use of anticoagulants
Current disease of the gastrointestinal tract aside from the current EoE diagnosis
Evidence of concurrent eosinophilic gastritis, enteritis, colitis, or proctitis
Evidence of active infection with Helicobacter pylori
Evidence of unstable asthma or changes in asthma or allergic rhinitis therapy within 1 month prior to the biopsy required for entrance to this study
Any female who is pregnant, who is planning to become pregnant, or who is breast-feeding
Current evidence or history of hypersensitivity or idiosyncratic reaction to budesonide or any other ingredients of the study medication
Current evidence of oropharyngeal or esophageal candidiasis
Receipt of an investigational drug within 30 days prior to the biopsy required for entrance to this study
Any condition or abnormality that, in the opinion of the Principal Investigator, would compromise the safety of the subject or successful conduct of the study
Clareo Health | Dose-Ranging Study of Oral Viscous Budesonide in Pediatrics With Eosinophilic Esophagitis
