UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019647 |
|---|---|
| Receipt number | R000022707 |
| Scientific Title | Investigation on the procedure of water loading test in Japanese healthy volunteers |
| Date of disclosure of the study information | 2015/11/06 |
| Last modified on | 2015/12/10 15:35:32 |
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Basic information
Public title
Investigation on the procedure of water loading test in Japanese healthy volunteers
Acronym
Investigation on the procedure of water loading test in Japanese healthy volunteers
Scientific Title
Investigation on the procedure of water loading test in Japanese healthy volunteers
Scientific Title:Acronym
Investigation on the procedure of water loading test in Japanese healthy volunteers
Region
| Japan |
Condition
Condition
urological diseases
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the examination schedule and procedure of water loading test after the administration of MINIRINMELT OD Tablet 120 microgram in Japanese healthy elderly female and male , and Japanese healthy non-elderly female volunteers. Also to observe the changes of urine volume and urinary osmolality.
In case of conducting the additional water loading test with different volume of water load, Japanese non-elderly male volunteers will be tested as well.
Basic objectives2
Others
Basic objectives -Others
To confirm the procedure
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Voided volume
Urinary osmolality
Urination speed
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
1. Water loading test
2. Single dose of 120 microgram Desmopressin
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)(a)(b)Age =>65 and Age <75 years. (at obtaining the informed consent)
(c)(d)Age =>20 and Age <40 years. (at obtaining the informed consent)
(2)(a)(b)Subject with weight =>40kg and <70kg (at screening test)
(c)(d)Subject with weight =>50kg and <80kg (at screening test)
(3) Subject with BMI
(a)=>17.5 and <30.5(at screening test)
(b)(c)(d)=>18.5 and <25.0(at screening test)
(4)The results of screening test are judged as eligible for this study subject by investigator
(5)Subject is able to consent and give the written informed consent form.
Key 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.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ippei Ikushima |
Organization
SOUSEIKAI Sumida Hospital
Division name
Physicians' Department
Zip code
Address
1-29-1 Honjo, Sumida-ku, Tokyo
TEL
03-5608-7276
ippei-ikushima@lta-med.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ippei Ikushima |
Organization
SOUSEIKAI Sumida Hospital
Division name
Physicians' Departmen
Zip code
Address
1-29-1 Honjo, Sumida-ku, Tokyo
TEL
03-5608-7276
Homepage URL
ippei-ikushima@lta-med.com
Sponsor or person
Institute
SOUSEIKAI Sumida Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 05 | Day |
Last modified on
| 2015 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022707
