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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01056783 |
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Date of registration:
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25/01/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Proof of Concept Study of OC000459 in Eosinophilic Esophagitis
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Scientific title:
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A Randomized, Placebo-controlled, Double-blind, Single-centre Proof-of-concept Study of OC000459 in Adult Patients With Active Eosinophilic Esophagitis |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01056783 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Alex Straumann, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Swiss EoE Research Group |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Eosinophilic Esophagitis
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Intervention(s)
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Drug: Placebo
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Drug: OC000459
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Primary Outcome(s)
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Effect of OC000459 on eosinophil load of the esophageal tissue
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Effect of OC000459 on EoE related blood and tissue biomarkers
[Time Frame: 8 weeks]
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Effect of OC000459 on clinical manifestations of EoE
[Time Frame: 8 weeks]
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Effect of OC000459 on endoscopic alterations
[Time Frame: 8 weeks]
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Safety and tolerability of OC000459 in patients with active EoE
[Time Frame: 8 weeks]
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Secondary ID(s)
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OC000459/013/09
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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