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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-UMIN000020701 |
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Date of registration:
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22/01/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma
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Scientific title:
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The efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma - The efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma |
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Date of first enrolment:
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2005/03/10 |
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Target sample size:
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40 |
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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=R000023888 |
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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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Not applicable
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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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Yasuhito Hamaguchi |
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Address:
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Takaramachi 13-1, Kanazawa
Japan |
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Telephone:
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076-265-2343 |
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Email:
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yasuhito@med.kanazawa-u.ac.jp |
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Affiliation:
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Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University Dermatology |
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Name:
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Yasuhito Hamaguchi |
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Address:
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Takaramachi 13-1, Kanazawa
Japan |
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Telephone:
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076-265-2343 |
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Email:
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yasuhito@med.kanazawa-u.ac.jp |
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Affiliation:
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Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University Dermatology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Patients who have a severe difficulty swallowing and who are unable to take orally the tablet. Patients who are judged to be inappropriate as a subject by physicians.
Age minimum:
Not applicable
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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reflux esophagitis associated with systemic scleroderma
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Intervention(s)
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Rabeprazole sodium 1 tablet a day will be added to subjects whose symptom does not improve with 1 tablet a day. The study will continue until subjects meet discontinuance criteria.
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Primary Outcome(s)
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The efficacy of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma
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Secondary Outcome(s)
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The safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma
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Source(s) of Monetary Support
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Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
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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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31/03/2023 |
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URL:
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