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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020580
Receipt No. R000023758
Scientific Title Pilot study of tranilast for cardiomyopathy of muscular dystrophy
Date of disclosure of the study information 2016/01/20
Last modified on 2017/01/15

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Basic information
Public title Pilot study of tranilast for cardiomyopathy of muscular dystrophy
Acronym Pilot study of tranilast for cardiomyopathy of muscular dystrophy
Scientific Title Pilot study of tranilast for cardiomyopathy of muscular dystrophy
Scientific Title:Acronym Pilot study of tranilast for cardiomyopathy of muscular dystrophy
Region
Japan

Condition
Condition muscular dystrophy
Classification by specialty
Cardiology Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects and safety of tranilast for cardiomyopathy of muscular dystrophy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Left ventricular fractional shortening, Left ventricular dilated dimension (before, 1 month, 3 months)
Key secondary outcomes Brain natriuretic peptide, cardiac troponin T, cardiac events (before, 1 month, 3 months)

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 Tranilast 300mg/day for three months (oral intake)
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 patients with muscular dystrophy
LVDd >=50%
LVFS < 20%
Key exclusion criteria Patients with severe hepatic dysfunction, renal dysfunction, eosinophilia or any other conditions unsuitable for taking tranilast
Target sample size 2

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Matsumura
Organization National Hospital Organization Toneyama National Hospital
Division name Neurology
Zip code
Address Toneyama 5-1-1, Toyonaka, Osaka Japan
TEL 06-6853-2001
Email tmatsumura-toneyama@umin.org

Public contact
Name of contact person
1st name
Middle name
Last name Tsuhoshi Matsumura
Organization National Hospital Organization Toneyama National Hospital
Division name Neurology
Zip code
Address Toneyama 5-1-1, Toyonaka, Osaka, Japan
TEL 06-6853-2001
Homepage URL
Email tmatsumura-toneyama@umin.org

Sponsor
Institute National Hospital Organization Toneyama National Hospital
Institute
Department

Funding Source
Organization National Hospital Organization Toneyama National Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor National Cerebral and Cardiovascular Center
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 国立病院機構刀根山病院

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 20 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
Two patients participated. BNP of both patients decreased after taking tranilast howevere no changes were found in UCG findings
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 Main results already published
Date of protocol fixation
2015 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 15 Day
Last follow-up date
2016 Year 05 Month 31 Day
Date of closure to data entry
2016 Year 06 Month 15 Day
Date trial data considered complete
2016 Year 07 Month 20 Day
Date analysis concluded
2016 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 01 Month 15 Day
Last modified on
2017 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023758

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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