UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016688 |
|---|---|
| Receipt number | R000019367 |
| Scientific Title | A study of the factor related to life-prolongation of patients with Duchenne muscular dystrophy |
| Date of disclosure of the study information | 2015/03/03 |
| Last modified on | 2020/07/12 10:46:56 |
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Basic information
Public title
A study of the factor related to life-prolongation of patients with Duchenne muscular dystrophy
Acronym
A study of the factor related to life-prolongation of DMD patients
Scientific Title
A study of the factor related to life-prolongation of patients with Duchenne muscular dystrophy
Scientific Title:Acronym
A study of the factor related to life-prolongation of DMD patients
Region
| Japan |
Condition
Condition
Duchenne muscular dystrophy
Classification by specialty
| Neurology | Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the factor that prolongs life expectancy of patients with Duchenne muscular dystrophy
Basic objectives2
Others
Basic objectives -Others
Time to death
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to death
Key secondary outcomes
Time at loss of ambulation
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Genetically confirmed as Duchenne muscular dystrophy
No limitation of disease stage.
No limitation of general condition.
No limitation of organ function (motor function, respiratory failure, cardiac failure, and dysphagia).
Patients with written informed consent.
In case of unable to make decision because of the age under 16 years or mental retardation, patient with written informed consent by parents or legal guardian.
Key exclusion criteria
Subject meets any of the following criteria is not enrolled in the study.
Not confirmed the diagnosis of DMD.
Subject considered to be an unsuitable candidate for the study by the Principal investigator or sub-investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Saito |
Organization
National Hospital Organization Osaka Toneyama Medical Center
Division name
Child Neurology, Neurology
Zip code
5608552
Address
5-1-1 Toneyama, Toyonaka, Osaka, Japan
TEL
06-6853-2001
saitot@toneyama.go.jp
Public contact
Name of contact person
| 1st name | Toshio |
| Middle name | |
| Last name | Saito |
Organization
National Hospital Organization Osaka Toneyama Medical Center
Division name
Clinical research center
Zip code
5608552
Address
5-1-1 Toneyama, Toyonaka, Osaka, Japan
TEL
06-6853-2001
Homepage URL
saitot@toneyama.go.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Center of Neurology and Psychiatry
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization
Address
2-5-23 Higasigaoka, Meguroku, Tokyo
Tel
03-5712-5075
kenkyu2004@hosp.go.jp
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
国立病院機構大阪刀根山医療センター（大阪），National Hospital Organization Osaka Toneyama Medical Center (Osaka)
国立病院機構東埼玉病院（埼玉），National Hospital Organization National Higashisaitama Hospital (Saitama)
国立病院機構あきた病院（秋田），National Hospital Organization National Akita Hospital (Akita)
国立病院機構仙台西多賀病院（宮城），National Hospital Organization National Sendai Nishitaga Hospital (Miyagi)
国立病院機構鈴鹿病院（三重），National Hospital Organization National Suzuka Hospital (Mie)
国立病院機構下志津病院（千葉），National Hospital Organization National Shimoshizu Hospital (Chiba)
国立病院機構長良医療センター（岐阜），National Hospital Organization Nagara Medical Center (Gifu)
国立病院機構長崎川棚医療センター（長崎），National Hospital Organization Nagasaki Kawatana Medical Center（Nagasaki）
国立病院機構大牟田病院（福岡）, National Hospital Organization Omuta National Hospital (Fukuoka)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 03 | 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
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
| 2017 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
In this study, we evaluate the following factor;
Effects of artificial ventilation and cardioprotection therapy,
Influence of modifier,
Influence of mutation of Dystrophin gene,
Gain of motor function and life prognosis.
Management information
Registered date
| 2015 | Year | 03 | Month | 03 | Day |
Last modified on
| 2020 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019367
