UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016188 |
|---|---|
| Receipt number | R000018787 |
| Scientific Title | Effect of tolvaptan in decompensated liver cirrhosis patients |
| Date of disclosure of the study information | 2015/01/12 |
| Last modified on | 2015/11/09 01:51:35 |
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Basic information
Public title
Effect of tolvaptan in decompensated liver cirrhosis patients
Acronym
Effect of tolvaptan inliver cirrhosis patients
Scientific Title
Effect of tolvaptan in decompensated liver cirrhosis patients
Scientific Title:Acronym
Effect of tolvaptan inliver cirrhosis patients
Region
| Japan |
Condition
Condition
decompensated liver cirrhosis patients
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was undertaken to assess the efficacy and predictors for response to tolvaptan before administration of this agent.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean differences between daily urine volume and body weight after administration of tolvaptan
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
This trial enrolled decompensated liver cirrhosis patients with ascites despite
undergoing combination therapy with a loop diuretic unless the subject is intolerant of diuretics
Key exclusion criteria
(1)The anuric patients
(2)Patients with urinary retention
(3) hypernatremia
(4)Patients with poorly controlled hepatocellular carcinoma and hepatic encephalopathy were exclude
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | uojima haruki |
Organization
shonan kamakura general hospital
Division name
department of gastroenterology
Zip code
Address
1370-1 okamoto,kamakura, kanagawa, japan
TEL
0467-46-1717
kiruha555@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | uojima haruki |
Organization
shonan kamakura general hospital
Division name
department of gastroenterology
Zip code
Address
1370-1 okamoto,kamakura, kanagawa, japan
TEL
0467-46-1717
Homepage URL
kiruha555@yahoo.co.jp
Sponsor or person
Institute
shonan kamakura general hospital
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
Name of secondary funder(s)
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
湘南鎌倉総合病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 02 | 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 | 11 | Month | 08 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 01 | Day |
Other
Other related information
The correlation between clinical effects to tolvaptan and predictors before administration of this agent.
Management information
Registered date
| 2015 | Year | 01 | Month | 12 | Day |
Last modified on
| 2015 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018787
