Back to resultsProof of Concept Study of OC000459 in Eosinophilic Esophagitis
Primary Purpose
Eosinophilic Esophagitis
Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
OC000459
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring EoE
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.
Sites / Locations
- Swiss EoE Research Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
OC000459
Placebo
Arm Description
OC000459 100mg twice daily
Outcomes
Primary Outcome Measures
Effect of OC000459 on eosinophil load of the esophageal tissue
Secondary Outcome Measures
Effect of OC000459 on clinical manifestations of EoE
Effect of OC000459 on endoscopic alterations
Effect of OC000459 on EoE related blood and tissue biomarkers
Safety and tolerability of OC000459 in patients with active EoE
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01056783
Brief Title
Proof of Concept Study of OC000459 in Eosinophilic Esophagitis
Official Title
A Randomized, Placebo-controlled, Double-blind, Single-centre Proof-of-concept Study of OC000459 in Adult Patients With Active Eosinophilic Esophagitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oxagen Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
EoE
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OC000459
Arm Type
Experimental
Arm Description
OC000459 100mg twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
OC000459
Intervention Description
OC000459 100mg, twice daily, tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets to match OC000459 tablets, twice daily
Primary Outcome Measure Information:
Title
Effect of OC000459 on eosinophil load of the esophageal tissue
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Effect of OC000459 on clinical manifestations of EoE
Time Frame
8 weeks
Title
Effect of OC000459 on endoscopic alterations
Time Frame
8 weeks
Title
Effect of OC000459 on EoE related blood and tissue biomarkers
Time Frame
8 weeks
Title
Safety and tolerability of OC000459 in patients with active EoE
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Straumann, Dr
Organizational Affiliation
Swiss EoE Research Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swiss EoE Research Group
City
Olten
ZIP/Postal Code
CH-4600
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Proof of Concept Study of OC000459 in Eosinophilic Esophagitis
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