UMIN-CTR Clinical Trial

Public title

Investigation on the procedure of water loading test in Japanese healthy male volunteers

Acronym

Investigation on the procedure of water loading test in Japanese healthy male volunteers

Scientific Title

Investigation on the procedure of water loading test in Japanese healthy male volunteers

Scientific Title:Acronym

Investigation on the procedure of water loading test in Japanese healthy male volunteers

Region

Japan

Condition

urological diseases

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the examination schedule and procedure of water loading test by evaluating urine volume and urinary osmolality after the administration of MINIRINMELT OD Tablet 60 microgram or 120 microgram in Japanese healthy male volunteers

Basic objectives2

Others

Basic objectives -Others

To confirm the procedure

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

AUC OSM
AUC urine production,
Time length which indicates urinary osmolality >200 mOsm/kg
Time length which indicates urination speed <0.12 mL/kg/min (up to 12 hours post dose)

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Maneuver

Interventions/Control_1

1. Water loading test
2. Single dose of 60microgram Desmopressin

Interventions/Control_2

1. Water loading test
2. Single dose of 120microgram Desmopressin

Interventions/Control_3

1. Water loading test
2. Single dose of Placebo

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

40

years-old

>

Gender

Male

Key inclusion criteria

(1)Age =>20 and Age <40 years. (at obtaining the informed consent)
(2)Subject with weight =>50kg and <80kg (at screening test)
(3) Subject with BMI =>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, 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 400ml or 200ml of blood within 12 weeks or 4 weeks respectively, or component blood within 2 weeks prior to study drug administration, respectively.
(17)Subject with positive test results of HIV antigen/antibody, HBs antigen, HCV antibody and/or syphilis.
(18) Subject who are considered to be inadequate for this study by investigator.

Target sample size

48

Name of lead principal investigator

1st name
Middle name
Last name	Ippei Ikushim

Organization

Medical Co. LTA Sumida Hospital

Division name

Physician's Department

Zip code

Address

1-29-1 Honjo, Sumida-ku, Tokyo

TEL

03-5608-7276

Email

ippei-ikushima@lta-med.com

Name of contact person

1st name
Middle name
Last name	Ippei Ikushima

Organization

Medical Co. LTA Sumida Hospital

Division name

Physician's Department

Zip code

Address

1-29-1 Honjo, Sumida-ku, Tokyo

TEL

03-5608-7276

Homepage URL

Email

ippei-ikushima@lta-med.com

Institute

Medical Co. LTA Sumida Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

墨田病院（東京都)

Date of disclosure of the study information

2015

Year

01

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

01

Month

15

Day

Date of IRB

Anticipated trial start date

2015

Year

01

Month

22

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

01

Month

20

Day

Last modified on

2015

Year

06

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018883