Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis
Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
Participant gender:
Summary
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.