Trial | NCT01056783  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    oc-000459 ...

  • Study Participants

    26
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.
Study Started
Aug 31
2010
Primary Completion
Jun 30
2011
Study Completion
Jun 30
2011
Last Update
Jan 05
2012
Estimate

Drug OC000459

OC000459 100mg, twice daily, tablet

Drug Placebo

Placebo tablets to match OC000459 tablets, twice daily

OC000459 Experimental

OC000459 100mg twice daily

Placebo Placebo Comparator

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.
No Results Posted