This will be a randomised, double blind, placebo controlled, parallel group evaluation of the
effect of OC000459 given orally for eight weeks on active eosinophilic esophagitis.
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Full eligibility criteria for NCT01056783
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT01056783
Swiss EoE Research Group
Olten, Switzerland, CH-4600
View full eligibility
Tris trial is registered with FDA with number: NCT01056783. The sponsor of the trial is Oxagen Ltd and it is looking for 26 volunteers for the current phase.
Official trial title: A Randomized, Placebo-controlled, Double-blind, Single-centre Proof-of-concept Study of OC000459 in Adult Patients With Active Eosinophilic Esophagitis
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