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Main
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Note: This record shows only the 20 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 November 2012 |
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Main ID: |
NCT01089543 |
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Date of registration:
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17/03/2010 |
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Primary sponsor: |
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Public title:
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A Study of E3810 for Japanese Subjects With Functional Dyspepsia (SAMURAI Study:Suppression of Acid Milieu With Rabeprazole Improving Functional Dyspepsia )
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Scientific title:
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A Multi-Center, Randomized, Double-Blind Study of E3810 for Japanese Subjects With Functional Dyspepsia |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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320 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01089543 |
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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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Countries of recruitment
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Japan
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Contacts
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Name:
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Masahiro Munesue |
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Address:
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Telephone:
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Email:
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Affiliation:
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Frontier Clinical Development Section. JAC PCU. Eisai Co., Ltd. |
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Key inclusion & exclusion criteria
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Inclusion criteria;
Subjects diagnosed as Functional Dyspepsia according to Rome III criteria.
Exclusion criteria;
Subjects with neuropsychiatric disorder.
Subjects diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious
constipation.
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Functional Dyspepsia
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Intervention(s)
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Drug: Placebo
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Drug: Rabeprazole
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Primary Outcome(s)
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Resolution rate of dyspeptic symptoms at last visit in treatment period
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Response rate of dyspeptic symptoms at last visit in treatment period
[Time Frame: 8 weeks]
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Secondary ID(s)
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E3810-J081-204
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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