Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal (GI) symptoms. There are no pharmacological treatments for EoE approved by the US Food and Drug Administration (FDA). Supported by published case series and controlled trials in children and adults, the most widely used drug treatment for EoE is off-label use of corticosteroids intended for local (esophageal mucosal) action. This study will evaluate the safety and tolerability of orally administered EUR-1100 once or twice daily. Eligible subjects will be randomized into one of the 3 treatment groups. The Treatment Period will be 8 weeks during which subjects will visit the clinic at the screening visit, randomization, week 4, 8 and 1 week after end of treatment for clinical symptom assessment and safety evaluation. Additional phone visits will occur at week 2 and week 6.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Active oral medication
matching placebo
Children's Center for Digestive Health
Atlanta, Georgia, United States
Northwestern University School of Medicine
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Mayo Clinic
Rochester, Minnesota, United States
South Jersey Pediatric Gastroenterology
Mays Landing, New Jersey, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
O&O Alpan LLC Center for Clinical Trials
Fairfax, Virginia, United States
Morning serum cortisol (change from baseline measure)
Time frame: Screening visit (up to 21 days), week 4, week 8 and follow-up
Standard safety laboratory tests
Hematology, serum chemistry and liver function tests, urinalysis, urine chemistry
Time frame: Screening visit (up to 21 days), week 4, week 8 and follow-up
Treatment-emergent adverse events collection
Time frame: Screening visit (up to 21 days), Randomization day, week 2 and week 6(phone visit), week 4 and week 8 (office visit), follow-up (office visit, up to 11 days after week 8 visit)
Physical examination and vital signs collection
Time frame: Screening (up to 21 days), week4, week 8 and follow-up
Esophagoduodenoscopy with multiple biopsies
Time frame: Screening (up to 21 days) and week 8
Patient reported outcomes, and physician global assessment
Time frame: Screening (up to 21 days), week 4 and 8.
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