UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation the introduction possibility on human experimental program with diuretics into the practical subject of pharmacology
Title of the study (Brief title)	Introduction possibility using diuretics on human experiment in pharmacologic study program
Region	Japan

Condition
Condition	Japanese healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The efficacy and safety assessment after oral dose of diuretics in order to investigate the introduction possibility on human experimental program into the practical subject of pharmacology.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison the diuretic effects in study drugs evaluated by urine volume, urine specific gravity and excretion volume of electrolytes in urine
Key secondary outcomes	Safety assessment (biomarkers of renal injury, vital measurement, serum electrolytes, excretion and adverse event)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Furosemide 20mg p.o. Single dose
Interventions/Control_2	Spironolactone 50mg p.o. Sigle dose
Interventions/Control_3	Tolvaptan 7.5mg p.o. Single dose
Interventions/Control_4	Biofermin p.o.(as a placebo) Single dose
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Subjects are competent to consent, keep the rules of the study and are able to report self condition. 2) Subjects who are judged eligible by the investigator in several series of medical check conducted prior to study.
Key exclusion criteria	1) Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc) and who is taking any drugs (including health supplements). 2) Any history for drug allergy 3) Subjects who are taking in too much alcohol 4) Subjects within three months after the participation to other clinical trials 5) Subjects who are inadequate for enrollment judged by the investigator.
Target sample size	6

Research contact person
Name of lead principal investigator	Naoki Uchida MD, PhD
Organization	Showa University School of Medicine
Division name	Department of Clinical Pharmacology
Address	6-11-11 Kitakarasuyama Setagaya-ku Tokyo 157-8577
TEL	03-3300-5254
Email	nuchida@med.showa-u.ac.jp

Public contact
Name of contact person	Naoki Uchida MD, PhD
Organization	Showa University School of Medicine
Division name	Department of Clinical Pharmacology
Address	6-11-11 Kitakarasuyama Setagaya-ku Tokyo 157-8577
TEL	03-3300-5254
Homepage URL
Email	nuchida@med.showa-u.ac.jp

Sponsor
Institute	Showa University School of Medicine Department of Clinical Pharmacology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	none
Name of secondary funｄer(s)	none

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	昭和大学臨床薬理研究所（東京都） Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics (Tokyo)

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 15 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date	2015 Year 10 Month 01 Day
Date of closure to data entry	2015 Year 11 Month 01 Day
Date trial data considered complete	2015 Year 12 Month 01 Day
Date analysis concluded	2016 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results	Safety All six subjects completed a trial. After Furosemide administration, hypotensive adverse event caused by excessive urination was observed in a female subject. No adverse event and no large change of the vital signs were observed in the other study drug administration in the female subject and the other study subjects. In addition, any safety parameters in blood and urine were not deviated from those reference range. The effectiveness The total urine volume after the study drug administration were Furosemide 1,903mL, Spironolactone 1,230mL, Tolvaptan 2,021mL, Placebo 963mL. The urine volume in all diuretics were significantly different compared to placebo. In addition, the urine collection period which showed the largest urine volume was matched with the tmax of each diuretics. And the duration of urine volume increase was also expressed the characteristic for the elimination half-life of the each administered diuretics. From the change of the total amount of electrolyte excretion, the distinction of Furosemide seemed to be possibility, but additional consideration would be necessary for clearly distinction of other diuretics.
Other related information

Management information
Registered date	2015 Year 05 Month 06 Day
Last modified on	2016 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000020213