UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046245 |
|---|---|
| Receipt number | R000052774 |
| Scientific Title | Database research to explore clinical patterns by region / medical institution type in neuromuscular diseases |
| Date of disclosure of the study information | 2021/12/07 |
| Last modified on | 2023/07/10 11:43:07 |
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Basic information
Public title
Database research to explore clinical patterns by region / medical institution type in neuromuscular diseases
Acronym
Database research to explore clinical patterns by region / medical institution type in neuromuscular diseases
Scientific Title
Database research to explore clinical patterns by region / medical institution type in neuromuscular diseases
Scientific Title:Acronym
Database research to explore clinical patterns by region / medical institution type in neuromuscular diseases
Region
| Japan |
Condition
Condition
neuromuscular disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory investigation of the effect of community / medical institution type on clinical patterns in the area of neuromuscular diseases where coordination between neurological medical care and rehabilitation is important.
Basic objectives2
Others
Basic objectives -Others
Exploratory investigation of the effect of community / medical institution type on clinical patterns in the area of neuromuscular diseases where coordination between neurological medical care and rehabilitation is important.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Status of concurrent diagnosis, frequency of medical treatment, medical expenses, period from the date of initial diagnosis to the start of medical treatment
Key secondary outcomes
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 and Female
Key inclusion criteria
Patients who have been diagnosed with the target neuromuscular disease during the enrollment period and can be continuously observed from March 2019 to February 2021
Key exclusion criteria
No setting
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Ouchi |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Medical Affairs Devision
Zip code
103-8324
Address
2-1-1 Muromachi, Nihonbashi, Chuo-ku, Tokyo
TEL
03-3273-0866
ohuchikor@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Sadaoki |
| Middle name | |
| Last name | Sakai |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Medical Affairs Devision
Zip code
103-8324
Address
2-1-1 Muromachi, Nihonbashi, Chuo-ku, Tokyo
TEL
03-3273-0866
Homepage URL
sakaisdo@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
MINS clinical trial review committee
Address
5-20-9-401 Mita, Minato-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2021 | Year | 12 | Month | 07 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/13/6/e070818.long
Publication of results
Published
Result
URL related to results and publications
https://bmjopen.bmj.com/content/13/6/e070818.long
Number of participants that the trial has enrolled
11940911
Results
https://bmjopen.bmj.com/content/13/6/e070818.long
Results date posted
| 2023 | Year | 07 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 06 | Month | 28 | Day |
Baseline Characteristics
https://bmjopen.bmj.com/content/13/6/e070818.long
Participant flow
https://bmjopen.bmj.com/content/13/6/e070818.long
Adverse events
https://bmjopen.bmj.com/content/13/6/e070818.long
Outcome measures
https://bmjopen.bmj.com/content/13/6/e070818.long
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 10 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 26 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 26 | Day |
Other
Other related information
Database research using JMDC's database (observation test)
Management information
Registered date
| 2021 | Year | 12 | Month | 01 | Day |
Last modified on
| 2023 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052774
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
