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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016188
Receipt No. 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

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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
Email 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
Email kiruha555@yahoo.co.jp

Sponsor
Institute shonan kamakura general hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018787

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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