UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017432
Receipt number R000020213
Scientific Title Investigation the introduction possibility on human experimental program with diuretics into the practical subject of pharmacology
Date of disclosure of the study information 2015/06/01
Last modified on 2016/04/09 11:58:26

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Basic information

Public title

Investigation the introduction possibility on human experimental program with diuretics into the practical subject of pharmacology

Acronym

Introduction possibility using diuretics on human experiment in pharmacologic study program

Scientific Title

Investigation the introduction possibility on human experimental program with diuretics into the practical subject of pharmacology

Scientific Title:Acronym

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)


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



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

1st name
Middle name
Last name Naoki Uchida MD, PhD

Organization

Showa University School of Medicine

Division name

Department of Clinical Pharmacology

Zip code


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

1st name
Middle name
Last name Naoki Uchida MD, PhD

Organization

Showa University School of Medicine

Division name

Department of Clinical Pharmacology

Zip code


Address

6-11-11 Kitakarasuyama Setagaya-ku Tokyo 157-8577

TEL

03-3300-5254

Homepage URL


Email

nuchida@med.showa-u.ac.jp


Sponsor or person

Institute

Showa University School of Medicine Department of Clinical Pharmacology

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

none

Name of secondary funder(s)

none


IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


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.

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 06 Month 15 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020213


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name