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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013095
Receipt No. R000015046
Scientific Title Multicenter study of the efficacy of tolvaptan for patients with refractory ascites.
Date of disclosure of the study information 2014/03/01
Last modified on 2018/09/07

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Basic information
Public title Multicenter study of the efficacy of tolvaptan for patients with refractory ascites.
Acronym Eeffect of tolvaptan on refractory ascites.
Scientific Title Multicenter study of the efficacy of tolvaptan for patients with refractory ascites.
Scientific Title:Acronym Eeffect of tolvaptan on refractory ascites.
Region
Japan

Condition
Condition Liver cirrhosis with refractory ascites.
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To elucidate the efficacy of tolvaptan, competitive vasopressin receptor 2 antagonist, for cirrhotic patients with reflactory ascites.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Decrease of body weight.
Key secondary outcomes Improvement of ascites.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Use tolvaptan for a refractory ascites patients.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients over 20 years old
2)Patients obtained written informed consent
3) Life expectancy of at least 4 weeks
4) Adequate organ function
a) Hb>= 8.0g/dL
b) neutrophil: >= 1,500/mm3
c) Platelet: >= 30,000/mm3
d) Total bilirubin:< 4.0 mg/dL
e) ALT and AST: <= within 6 folds of normal limit
f) Serum creatine: <= 2.0 mg/dL
g) Serum natrium: >= 120mEq/L
Key exclusion criteria 1) Adequate cardiac organ function
a) Patients with conjestive heart failure above NYHA class3
b) Patients with severe hypertension
2) Patients with severe and active infectious disease (exclude HBV,HCV hepatitis)
3) Patients with HIV
4) Patients taking dialysis
5) Patients with portal tumor thrombosis (Vp3 or Vp4)
6) Patients with hepatic encephalopathy
7) Patients with crutial digestive bleedings within 4 weeks
8) Patients with the following treatment
a) Systemic chemotherapy
b) Being treated with invasive surgical therapy within 4 weeks
9) Patients with oral intake difficulty
10)Patients with severe digestive diseases
11)Patients taking a tablet which would affect this clinical study
12)Pregnant woman, lactating woman, or a woman suspected of pregnancy
13)Patients with severe allergic reaction to Tolvaptan
14)Patients with drug abuse or psycological disorders
15) Patients concluded to be inappropriate to participate in this study by their physitians
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideto Kawaratani
Organization Nara Medical University
Division name The third department of internal medicine
Zip code
Address Shijyo-cho 840, Kashihara, Nara, Japan
TEL 0744-22-3051(3415)
Email kawara@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideto Kawaratani
Organization Nara Medical University
Division name The third department of internal medicine
Zip code
Address Shijyo-cho 840, Kashihara, Nara, Japan
TEL 0744-22-3051(3415)
Homepage URL
Email kawara@naramed-u.ac.jp

Sponsor
Institute Tht third department of internal medicine, Nara Medical University
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)

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 奈良県立医科大学附属病院(奈良県)
奈良県立奈良病院(奈良県)
独立行政法人国立病院機構 奈良医療センター(奈良県)
県立五條病院(奈良県)
国保中央病院(奈良県)
県立三室病院(奈良県)
高の原中央病院(奈良県)
西奈良中央病院(奈良県)
大倭病院(奈良県)
高宮病院(奈良県)
服部記念病院(奈良県)
平成記念病院(奈良県)
済生会御所病院(奈良県)
ベルランド総合病院(大阪府)
医真会八尾総合病院(大阪府)
堺若葉会病院(大阪府)
その他臨床研究賛同施設

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 01 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 No longer recruiting
Date of protocol fixation
2014 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Factors to consider the relevance and results

Management information
Registered date
2014 Year 02 Month 06 Day
Last modified on
2018 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015046

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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