A Randomized, Placebo-controlled, Double-blind, Single-centre Proof-of-concept Study of OC000459 in Adult Patients With Active Eosinophilic Esophagitis

Oxagen Ltd1 site in 1 country26 target enrollmentAugust 2010

ConditionsEosinophilic Esophagitis

InterventionsOC000459 Placebo

DrugsOC000459 Placebo

Overview

Phase: Phase 2
Intervention: OC000459
Conditions: Eosinophilic Esophagitis
Sponsor: Oxagen Ltd
Enrollment: 26
Locations: 1
Primary Endpoint: Effect of OC000459 on eosinophil load of the esophageal tissue
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

June 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Oxagen Ltd

Responsible Party

Sponsor

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.