Proof of Concept Study of OC000459 in Eosinophilic Esophagitis

Launched by OXAGEN LTD · Jan 25, 2010

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Previously diagnosed and symptomatic isolated eosinophilic esophagitis.
• • Relevant eosinophil tissue inflammation as demonstrated by a mean eosinophil load \>= 20 eos/hpf in 8 biopsies at the baseline visit.
• • Able to swallow placebo medication successfully under supervision in the clinic
• • Free of all medications for EoE (including topical steroids) for at least 2 weeks prior to baseline and free of systemic steroids for at least 90 days before screening. A proton-pump inhibitor is allowed if required for treatment of secondary acid reflux.
• Exclusion Criteria:
• • Other causes of esophagitis (GERD, peptic ulceration, infection etc.)
• • Other causes of eosphagaeal or generalized eosinophilia (i.e. hypereosinophilic syndromes, parasitic infection, GERD)
• • The patient's EoE is dependant on the level of seasonal allergens and the patient's participation in the study will occur during the allergy season.
• • History of abnormal gastric or duodenal eosinophilia (e.g. HES, Churg Strauss vasculitis, EG or a parasitic infection)
• • Receipt of forbidden prescribed or over the counter medication within the 4 weeks prior to the baseline visit and for the duration of the trial, including vitamins and herbal remedies.