UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015218 |
|---|---|
| Receipt number | R000017694 |
| Scientific Title | The Randomized Controlled Trial for Evaluating the Efficacies of Tolvaptan in Patients with ascites in hepatic edema |
| Date of disclosure of the study information | 2014/09/24 |
| Last modified on | 2016/08/31 23:55:02 |
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Basic information
Public title
The Randomized Controlled Trial for Evaluating the Efficacies of Tolvaptan in Patients with ascites in hepatic edema
Acronym
The Efficacies of Tolvaptan in Patients with ascites in hepatic edema
Scientific Title
The Randomized Controlled Trial for Evaluating the Efficacies of Tolvaptan in Patients with ascites in hepatic edema
Scientific Title:Acronym
The Efficacies of Tolvaptan in Patients with ascites in hepatic edema
Region
| Japan |
Condition
Condition
liver cirrhosis
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the efficacies of tolvaptan in patient with ascites in hepatic edema, by comparing with the treatment which increases the dose of furosemide.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
change of body weight
Key secondary outcomes
1) change of volume of ascites
2) change of urine output
3) symptoms of volume overload
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Add oral tolvaptan 7.5mg/day to the conventional therapy for a week
Interventions/Control_2
Add oral furosemide 40mg/day to the conventional therapy for a week
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients with liver cirrohsis with ascites in hepatic edema.
2)Patients given oral furosemide 20-100mg/day and Spironolactone 25mg-200mg at the time of enrolling.
Key exclusion criteria
1)The anuric patients
4)Patients with urinary retention
3)Serum Na >=147mEq/L
Target sample size
60
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
| 2014 | Year | 09 | Month | 24 | 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 | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 20 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 20 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 21 | Day |
Last modified on
| 2016 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017694
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
