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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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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000014668 |
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Date of registration:
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15/08/2014 |
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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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A Randomized Controlled Trial compares the efficacy of Moviprep vs Muben on the bowel preparation of the patients who undergo colorectal endoscopic submucosal dissection
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Scientific title:
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A Randomized Controlled Trial compares the efficacy of Moviprep vs Muben on the bowel preparation of the patients who undergo colorectal endoscopic submucosal dissection - MOVI STUDY |
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Date of first enrolment:
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2014/08/15 |
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Target sample size:
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100 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017061 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Phase II
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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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Masayoshi Yamada |
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Address:
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5-1-1, Tsukiji, Chuo-ku, Tokyo
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Telephone:
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+81-3-3542-2511 |
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Email:
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masyamad@ncc.go.jp |
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Affiliation:
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National Cancer Center Hospital Endoscopy Division |
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Name:
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Takahisa Matsuda |
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Address:
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5-1-1, Tsukiji, Chuo-ku, Tokyo
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Telephone:
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+81-3-3542-2511 |
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Email:
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tamatsud@ncc.go.jp |
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Affiliation:
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National Cancer Center Hospital Endoscopy Division |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1. Patients having risk of perforation, obstruction and suspicious of ileum. 2. Toxic megacolon 3. Allergy for Moviprep and Muben 4. Dehydration 5. Mental disease 6. Without written informed consent 7. Angina pectoris and/or past history of myocardial infarction within 6 months. 8. Active inflammatory bowel diseases 9. Past history of convulsive attack 10. Serum creatinine level ≥1.3 mg/dL 11. Others (depends on the chief physician)
Age minimum:
20years-old
Age maximum:
75years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Colorectal tumor
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Intervention(s)
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Moviprep 1.5L ~ 2L
Muben 3L ~ 4L
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Primary Outcome(s)
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Preparation time
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Secondary Outcome(s)
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Boston Bowel Preparation Scale score, acceptability, taste, frequencies of stool, total volume of the prep, complication rate.
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Source(s) of Monetary Support
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Ajinomoto Pharmaceuticals Co., LTD
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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15/08/2015 |
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URL:
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