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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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16 December 2017 |
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Main ID: |
NCT02098473 |
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Date of registration:
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25/03/2014 |
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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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Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis
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Scientific title:
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A Phase2, Multi-Center, Multi-national, Randomized, Double-blind, Placebo-controlled Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of RPC4046 in Adult Subjects With Eosinophilic Esophagitis |
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Date of first enrolment:
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August 31, 2014 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02098473 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Switzerland
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologic evidence of EoE
- Clinical symptoms of EoE including dysphagia
Exclusion Criteria:
- Primary causes of esophageal eosinophilia other than EoE
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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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: RPC4046
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Primary Outcome(s)
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Mean Eosinophil Count
[Time Frame: Week 16]
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Secondary ID(s)
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RPC02-201
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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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