Proof of Concept Study of OC000459 in Eosinophilic Esophagitis

Oxagen

Status and phase

Completed

Phase 2

Conditions

Eosinophilic Esophagitis

Treatments

Drug: Placebo

Drug: OC000459

Study type

Interventional

Funder types

Industry

Identifiers

NCT01056783

OC000459/013/09

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.