UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008396 |
|---|---|
| Receipt number | R000009874 |
| Scientific Title | A randomized, double-blind, placebo-controlled trial of diflunisal on familial amyloid polyneuropathy |
| Date of disclosure of the study information | 2012/07/10 |
| Last modified on | 2016/01/11 15:42:12 |
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Basic information
Public title
A randomized, double-blind, placebo-controlled trial of diflunisal on familial amyloid polyneuropathy
Acronym
A trial of diflunisal on familial amyloid polyneuropathy
Scientific Title
A randomized, double-blind, placebo-controlled trial of diflunisal on familial amyloid polyneuropathy
Scientific Title:Acronym
A trial of diflunisal on familial amyloid polyneuropathy
Region
| Japan |
Condition
Condition
patients of familial amyloid polyneuropathy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To develop a new medicine with little invention and wide indication
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
clinical manifestation
Key secondary outcomes
nerve conduction study data
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Diflunisal, 500mg / day, PO, 1 year
Interventions/Control_2
Parse, 500mg / day, PO, 1 year
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients of familial amyloid polyneuropathy
Key exclusion criteria
patients after liver transplantation
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taro Yamashita |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Neurology
Zip code
Address
1-1-1, Konjo, Kumamoto
TEL
096-373-5893
taro-yamashita@fc.kuh.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taro Yamashita |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Neurology
Zip code
Address
1-1-1, Honjo, Kumamoto
TEL
096-373-5893
Homepage URL
taro-yamashita@fc.kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Neurology, Faculty of Life Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Department of Neurology, Faculty of Life Sciences, Kumamoto University
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
| 2012 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 10 | Day |
Last modified on
| 2016 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009874
