Proof of Concept Study of OC000459 in Eosinophilic Esophagitis

NCT ID: NCT01056783

Last Updated: 2012-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-06-30

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.

Conditions

Eosinophilic Esophagitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

OC000459

OC000459 100mg twice daily

Group Type: EXPERIMENTAL

OC000459

Intervention Type: DRUG

OC000459 100mg, twice daily, tablet

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablets to match OC000459 tablets, twice daily

Interventions

OC000459

OC000459 100mg, twice daily, tablet

Intervention Type: DRUG

Placebo

Placebo tablets to match OC000459 tablets, twice daily

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oxagen Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex Straumann, Dr

Role: PRINCIPAL_INVESTIGATOR

Swiss EoE Research Group

Locations

Swiss EoE Research Group

Olten, , Switzerland

Countries

Switzerland

Other Identifiers

OC000459/013/09

Identifier Type: -

Identifier Source: org_study_id