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
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2010
CompletedFirst Posted
Study publicly available on registry
January 26, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJanuary 5, 2012
January 1, 2012
10 months
January 25, 2010
January 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of OC000459 on eosinophil load of the esophageal tissue
8 weeks
Secondary Outcomes (4)
Effect of OC000459 on clinical manifestations of EoE
8 weeks
Effect of OC000459 on endoscopic alterations
8 weeks
Effect of OC000459 on EoE related blood and tissue biomarkers
8 weeks
Safety and tolerability of OC000459 in patients with active EoE
8 weeks
Study Arms (2)
OC000459
EXPERIMENTALOC000459 100mg twice daily
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oxagen Ltdlead
Study Sites (1)
Swiss EoE Research Group
Olten, CH-4600, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alex Straumann, Dr
Swiss EoE Research Group
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2010
First Posted
January 26, 2010
Study Start
August 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
January 5, 2012
Record last verified: 2012-01