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. |
Register:
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JPRN |
Last refreshed on:
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17 October 2023 |
Main ID: |
JPRN-UMIN000019647 |
Date of registration:
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06/11/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Investigation on the procedure of water loading test in Japanese healthy volunteers
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Scientific title:
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Investigation on the procedure of water loading test in Japanese healthy volunteers - Investigation on the procedure of water loading test in Japanese healthy volunteers |
Date of first enrolment:
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2015/11/09 |
Target sample size:
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42 |
Recruitment status: |
Complete: follow-up complete |
URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022707 |
Study type:
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Interventional |
Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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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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Ippei Ikushima |
Address:
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1-29-1 Honjo, Sumida-ku, Tokyo
Japan |
Telephone:
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03-5608-7276 |
Email:
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ippei-ikushima@lta-med.com |
Affiliation:
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SOUSEIKAI Sumida Hospital Physicians' Departmen |
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Name:
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Ippei Ikushima |
Address:
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1-29-1 Honjo, Sumida-ku, Tokyo
Japan |
Telephone:
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03-5608-7276 |
Email:
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ippei-ikushima@lta-med.com |
Affiliation:
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SOUSEIKAI Sumida Hospital Physicians' Department |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: (1)Subject with present illness. (2)Subject who has past medical history judged by investigator as an influence evaluate subject safety. (e.g. liver diseases, kidney diseases, cardiovascular diseases, hematologic diseases, endocrine system diseases, diseases of digestive system, diseases of respiratory system, mental disorders, infectious diseases, etc.) (3)Subject with diseases which possibly influence release and/or absorption of study drug ingredients. (4)Serum Na <137 mEq/L at screening test or a day before study drug administration. (5)Urination speed 0.12mL/kg/min from -30min to the time just before the study drug administration. (6)Subject had nausea and/or vomiting with water loading test at pre dosing. (7)History or presence of drug and/or alcohol dependence. (8) History or presence of drug allergy. (9) History or presence of food allergy. (10)Subject who take alcohol =>20g/day. (11)Dosing of any drug or supplements within 2 weeks prior to study drug administration. (12)Subject who smoked after screening test. (13)Subject who took food or beverages containing grapefruit (juice, flesh) within 3 days prior to study drug administration. (14)Use of other study drug for other clinical study within 12 weeks prior to study drug administration. (15)Subject who participated in other clinical study for medical devices within 12 weeks prior to study drug administration. (16) Subject who donated more than 400mlof blood within 12 weeks (male) /16 weeks (female), 200ml of blood within 4 weeks, or component blood within 2 weeks prior to study drug administration. For elderly subjects, besides the above criteria, investigators should take their health condition into consideration. (17)Subject with positive test results of HIV antigen/antibody, HBs antigen, HCV antibody and/or syphilis. (18)(c)Non-elderly female who are menstruating, pregnant or lactating on the day of the water loading test. (19) Subject who are considered to be inadequate for this study by investigator.
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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urological diseases
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Intervention(s)
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1. Water loading test 2. Single dose of 120 microgram Desmopressin
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Primary Outcome(s)
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Voided volume Urinary osmolality Urination speed
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Source(s) of Monetary Support
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None
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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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Date Posted:
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Date Completed:
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URL:
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