UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001670 |
|---|---|
| Receipt number | R000002018 |
| Scientific Title | Effect of tranilast on liver pathology in patients with nonalcoholic fatty liver disease and allergic diseases |
| Date of disclosure of the study information | 2009/01/30 |
| Last modified on | 2014/09/01 15:10:40 |
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Basic information
Public title
Effect of tranilast on liver pathology in patients with nonalcoholic fatty liver disease and allergic diseases
Acronym
Tranilast for treatment of nonalcoholic steatohepatitis
Scientific Title
Effect of tranilast on liver pathology in patients with nonalcoholic fatty liver disease and allergic diseases
Scientific Title:Acronym
Tranilast for treatment of nonalcoholic steatohepatitis
Region
| Japan |
Condition
Condition
patients with nonalcoholic fatty liver
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Liver histology of non nonalcoholic fatty liver
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Liver histology of non nonalcoholic fatty liver
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
tranilast
Interventions/Control_2
control
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
NAFLD
Key exclusion criteria
HBV infection, HCV infection,
pregnancy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | yumie TAKESHITA |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Disease Control and Homeostasis
Zip code
Address
13-1 Takara-machi Kanazawa Ishikawa 920-8641 Japan
TEL
076-265-2233
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | masafumi UNO |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Disease Control and Homeostasis
Zip code
Address
13-1 Takara-machi Kanazawa Ishikawa 920-8641 Japan
TEL
076-265-2233
Homepage URL
unomasa1977@yahoo.co.jp
Sponsor or person
Institute
Kanazawa University Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University Graduate School of Medical Science
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 01 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2008 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 01 | Month | 30 | Day |
Last modified on
| 2014 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002018
