|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-UMIN000020580 |
|
Date of registration:
|
20/01/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Pilot study of tranilast for cardiomyopathy of muscular dystrophy
|
|
Scientific title:
|
Pilot study of tranilast for cardiomyopathy of muscular dystrophy - Pilot study of tranilast for cardiomyopathy of muscular dystrophy |
|
Date of first enrolment:
|
2016/01/15 |
|
Target sample size:
|
2 |
|
Recruitment status: |
Complete: follow-up complete |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023758 |
|
Study type:
|
Interventional |
|
Study design:
|
Single arm Non-randomized
|
|
Phase:
|
Not applicable
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Tsuhoshi Matsumura |
|
Address:
|
Toneyama 5-1-1, Toyonaka, Osaka, Japan
Japan |
|
Telephone:
|
06-6853-2001 |
|
Email:
|
tmatsumura-toneyama@umin.org |
|
Affiliation:
|
National Hospital Organization Toneyama National Hospital Neurology |
|
|
Name:
|
Tsuyoshi Matsumura |
|
Address:
|
Toneyama 5-1-1, Toyonaka, Osaka Japan
Japan |
|
Telephone:
|
06-6853-2001 |
|
Email:
|
tmatsumura-toneyama@umin.org |
|
Affiliation:
|
National Hospital Organization Toneyama National Hospital Neurology |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: Patients with severe hepatic dysfunction, renal dysfunction, eosinophilia or any other conditions unsuitable for taking tranilast
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
muscular dystrophy
|
|
Intervention(s)
|
|
Tranilast 300mg/day for three months (oral intake)
|
|
Primary Outcome(s)
|
|
Left ventricular fractional shortening, Left ventricular dilated dimension (before, 1 month, 3 months)
|
|
Secondary Outcome(s)
|
|
Brain natriuretic peptide, cardiac troponin T, cardiac events (before, 1 month, 3 months)
|
|
Source(s) of Monetary Support
|
|
National Hospital Organization Toneyama National Hospital
|
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
31/05/2016 |
|
URL:
|
|
|
|