UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010680 |
|---|---|
| Receipt number | R000012227 |
| Scientific Title | Evaluation of the Chiba alliance medical path-stroke (Durg sheet) |
| Date of disclosure of the study information | 2013/05/09 |
| Last modified on | 2022/12/16 15:57:20 |
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Basic information
Public title
Evaluation of the Chiba alliance medical path-stroke (Durg sheet)
Acronym
Evaluation of the Chiba alliance medical path-stroke (Durg sheet)
Scientific Title
Evaluation of the Chiba alliance medical path-stroke (Durg sheet)
Scientific Title:Acronym
Evaluation of the Chiba alliance medical path-stroke (Durg sheet)
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the Chiba alliance medical path-stroke (drug sheet).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Control item of Stroke patients
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' use of the Chiba alliance medical path-stroke (drug sheet)
Key exclusion criteria
Not applicable
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | IIJIMA |
Organization
Chiba Pharmaceutical Association
Division name
Drug Information Center
Zip code
260-0025
Address
9-2 Tonyacho, Chuo-ku, Chiba-shi, Chiba, 260-0025 Japan
TEL
043-247-4401
h-iijima@c-yaku.or.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | IIJIMA |
Organization
Chiba Pharmaceutical Association
Division name
Drug Information Center
Zip code
260-0025
Address
9-2 Tonyacho, Chuo-ku, Chiba-shi, Chiba 260-0025, Japan
TEL
043-247-4401
Homepage URL
drug-info@c-yaku.or.jp
Sponsor or person
Institute
Chiba Pharmaceutical Association
Institute
Department
Personal name
Funding Source
Organization
Chiba Pharmaceutical Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board, Chiba Pharmaceutical Association
Address
9-2 Tonyacho, Chuo-ku, Chiba-shi, Chiba, 260-0025 Japan
Tel
043-247-4401
drug-info@c-yaku.or.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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 09 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
34
Results
Age of study patients were 66.2 years and 38.2% for modified Rankin Scale 4. period between draw up and B obtain of drug sheet was 11.0 days, obtain and use was 3.1 days.
Results date posted
| 2022 | Year | 12 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
severity0: 5.9%, severity1: 23.5%, severity2: 23.5%, severity3: 8.8%, severity4: 38.2%, severity5: 0.0%, severity 6: 0.0%
Participant flow
N/A
Adverse events
Absence
Outcome measures
day of transmission
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 01 | Day |
Other
Other related information
Observation of general treatment at drug sheet
Management information
Registered date
| 2013 | Year | 05 | Month | 09 | Day |
Last modified on
| 2022 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012227
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
