Proof of Concept Study of OC000459 in Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056783
• Other study ID #: OC000459/013/09
• Status: Completed
• Phase: Phase 2
• First received: January 25, 2010
• Last updated: January 4, 2012
• Start date: August 2010
• Est. completion date: June 2011

Study information

• Verified date: January 2012
• Source: Oxagen Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Drug:
• OC000459
OC000459 100mg, twice daily, tablet
• Placebo
Placebo tablets to match OC000459 tablets, twice daily

Locations

Country	Name	City	State
Switzerland	Swiss EoE Research Group	Olten

Sponsors (1)

Lead Sponsor	Collaborator
Oxagen Ltd

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of OC000459 on eosinophil load of the esophageal tissue		8 weeks	No
Secondary	Effect of OC000459 on clinical manifestations of EoE		8 weeks	No
Secondary	Effect of OC000459 on endoscopic alterations		8 weeks	No
Secondary	Effect of OC000459 on EoE related blood and tissue biomarkers		8 weeks	No
Secondary	Safety and tolerability of OC000459 in patients with active EoE		8 weeks	Yes