UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020580 |
|---|---|
| Receipt number | 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 09:42:11 |
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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
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
tmatsumura-toneyama@umin.org
Sponsor or person
Institute
National Hospital Organization Toneyama National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023758
