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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-UMIN000030327 |
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Date of registration:
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22/12/2017 |
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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 clinical trial of lubiprostone's effect on chronic enteropathy associated with SLCO2A1
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Scientific title:
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Proof-of-concept clinical trial of lubiprostone's effect on chronic enteropathy associated with SLCO2A1 - LEAC study |
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Date of first enrolment:
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2017/12/25 |
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Target sample size:
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8 |
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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=R000034635 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase I,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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Naoki Ohmiya |
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Address:
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1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
Japan |
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Telephone:
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0562-93-9240 |
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Email:
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nohmiya@fujita-hu.ac.jp |
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Affiliation:
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Fujita Health University Department of Gastroenterology |
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Name:
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Naoki Ohmiya |
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Address:
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1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
Japan |
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Telephone:
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0562-93-9240 |
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Email:
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nohmiya@fujita-hu.ac.jp |
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Affiliation:
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Fujita Health University Department of Gastroenterology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Contraindications of enteroscopy 2) Bad conditions such as small bowel obstruction 3) Severe cardiac or pulmonary disease 4) Allergy to lubiprostone or contraindications of lubiprostone 5) Within 1 month of another clinical trial 6) Pregnant or lactating women 7) Man or woman who does not comply with this trial 8) Inappropriate situations judged by attending doctors
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Nonspecific multiple ulcers in the small intestine unrelated to NSAID (Chronic enteropathy associated with SLCO2A1: CEAS)
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Intervention(s)
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lubiprostone(12 micrograms) for 8 weeks
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Primary Outcome(s)
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1) Enteroscopic improvement after lubiprotone treatment 2) Endocmicroscopic improvement of leaky gut syndrome
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Secondary Outcome(s)
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1)Serum iron, ferritin, total protein, and albumin 2) Urine PGE-MUM/Cr 3) Fecal calprotectin 4) Oter blood test data 5) Symptomatic improvement 6) Pathologic change 7) Bowel movements
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Source(s) of Monetary Support
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Mylan EPD G.K.
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Ethics review
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Status: YES
Approval date: 09/06/2017
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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28/03/2019 |
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Date Completed:
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31/12/2018 |
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URL:
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