UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002768 |
|---|---|
| Receipt number | R000003039 |
| Scientific Title | Effectiveness of pioglitanone hydrochloride on cerebral vasospasm after subarachnoid hemorrhage (SAH) |
| Date of disclosure of the study information | 2009/12/01 |
| Last modified on | 2014/05/16 16:45:53 |
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Basic information
Public title
Effectiveness of pioglitanone hydrochloride on cerebral vasospasm after subarachnoid hemorrhage (SAH)
Acronym
Effect of pioglitazone on vasospasm after SAH
Scientific Title
Effectiveness of pioglitanone hydrochloride on cerebral vasospasm after subarachnoid hemorrhage (SAH)
Scientific Title:Acronym
Effect of pioglitazone on vasospasm after SAH
Region
| Japan |
Condition
Condition
subarachnoid hemorrhage
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
effect of pioglitazone to vasospasm
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
functional prognosis (modified-Ranking Scale), evaluation of vasospasm by angiography, evaluation of cerebral infarction by CT or MRI
Key secondary outcomes
evaluation of adverse reaction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of pioglitazone
Interventions/Control_2
administration of placebo
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patient who was admitted with subarachnoid hemorrhage, blood sugar over 80 mg/dl at any time.
Key exclusion criteria
old person over 90 year-old, medicine hypersensitivity patient, pregnant woman or woman who has pregnancy possibly, hypoglycemia, person who was judged inadequat as patient by doctor.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Kasuya |
Organization
Tokyo Womens Medical University Medical Center East
Division name
Department of Neurosurgery
Zip code
Address
Nishiogu 2-1-10 Arakawa-ku Tokyo
TEL
03-3810-1111
kasuya@dnh.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiegru Tani |
Organization
Tokyo Womens Medical University Medical Center East
Division name
Department of Neurosurgery
Zip code
Address
Nishiogu 2-1-10 Arakawa-ku Tokyo
TEL
03-3810-1111
Homepage URL
http://www.dnh.twmu.ac.jp
stanine@dnh.twmu.ac.jp
Sponsor or person
Institute
Tokyo Womens Medical University Medical Center East
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
東京女子医科大学 東医療センター （東京都）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 11 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 16 | Day |
Last modified on
| 2014 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003039
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
