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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017432
Receipt No. 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

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

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
URL(English) https://upload.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


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