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
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
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
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
