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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003063
Receipt No. R000003718
Scientific Title MATRIX(Migrainer Assess TRiptane eXamination)
Date of disclosure of the study information 2010/01/20
Last modified on 2011/01/24

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Basic information
Public title MATRIX(Migrainer Assess TRiptane eXamination)
Acronym MATRIX
Scientific Title MATRIX(Migrainer Assess TRiptane eXamination)
Scientific Title:Acronym MATRIX
Region
Japan

Condition
Condition migraine
Classification by specialty
Medicine in general Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 non-randomized open label trial to compare multiple triptane medications for the outpatient with migraine
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Effect of Triptane medication evaluated wtih VAS and SF36
Key secondary outcomes Side effect of Triptane
Relation of VAS and SF36

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 sumatriptan
Interventions/Control_2 eletriptan
Interventions/Control_3 zolmitriptan
Interventions/Control_4 rizatriptan
Interventions/Control_5 naratriptan
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 diagnosed as migraine
Key exclusion criteria Ischemic heart disease, old age, medication overuse headache
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Shibata
Organization University of Tsukuba
Mito Medical Center
Division name Department of Neurosurgery
Zip code
Address 3-2-7 Miyamachi, Mito, Ibaraki
TEL 029-231-2371
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Shibata
Organization University of Tsukuba
Division name Department of Neurosurgery
Zip code
Address 3-2-7 Miyamachi, Mito, Ibaraki
TEL 029-231-2371
Homepage URL
Email

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Astra Zeneca
Organization
Division
Category of Funding Organization Profit 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 筑波大学水戸地域医療教育センター/水戸協同病院(茨城県)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2010 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2011 Year 01 Month 01 Day
Date of closure to data entry
2011 Year 01 Month 01 Day
Date trial data considered complete
2011 Year 01 Month 01 Day
Date analysis concluded
2011 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 20 Day
Last modified on
2011 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003718

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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