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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name