A Six Month, Safety Follow-up Study in Eosinophilic Esophagitis Subjects Who Completed Study PR-021
Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
This purpose of this study is the long-term follow-up of glucocorticosteroid-related adverse
events and hypothalamic-pituitary-adrenal axis (HPA) suppression in subjects after
discontinuation of study drug received in the PR-021 study (Safety and Tolerability Study of
Oral EUR-1100 to Treat Eosinophilic Esophagitis). The study will also provide the opportunity
to better understand the natural course of eosinophilic esophagitis and define the treatment
modalities of eosinophilic esophagitis with EUR-1100, such as the need for chronic
maintenance or intermittent treatment.
All subjects who complete PR-021 will be offered the opportunity to participate in this
study. The duration of this follow-up study is six months, during which subjects will visit
the clinic for safety evaluation and clinical symptom assessment at the screening, Week 8,
Week 16, and Week 24 visits. Additional phone visits will occur at Week 4, Week 12, and Week
20.