UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002768
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email stanine@dnh.twmu.ac.jp

Sponsor
Institute Tokyo Womens Medical University Medical Center East
Institute
Department

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
Email

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
URL(English) https://upload.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


Contact us.