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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000293
Receipt No. R000000370
Scientific Title Outcome Assessment using SF-36 v2 in Stroke Patient Study
Date of disclosure of the study information 2008/05/31
Last modified on 2007/12/11

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Basic information
Public title Outcome Assessment using SF-36 v2 in Stroke Patient Study
Acronym OASIS STUDY
Scientific Title Outcome Assessment using SF-36 v2 in Stroke Patient Study
Scientific Title:Acronym OASIS STUDY
Region
Japan

Condition
Condition Brain infarction
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To survey the health-related quality of life (HRQOL) using the SF-36 v2 score of patients with chronic brain infarction in Japan
Basic objectives2 Others
Basic objectives -Others Survey of present condition and prognosis of chronic brain infarction
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To determine the SF-36 v2 score and to investigate the effect on QOL of vertigo, dizziness, presyncope, and light-headedness after chronic brain infarction
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 1. Patients whose last attack occurred more than 1 month ago
2. Outpatients (including hospitalization for rehabilitation)
3. Japanese nationality
4. Patients who consented to participate in this study
5. Group I: Patients with dizziness, vertigo, presyncope, and light-headedness which are likely due to secondary chronic cerebral circulation impairment associated with sequelae of brain infarction, and patients for whom KETAS (IBUDILAST) was prescribed
Group II: Patients without dizziness, vertigo, presyncope, and light-headedness which are likely due to chronic cerebral circulation impairment associated with sequelae of brain infarction
Key exclusion criteria 1. Patients who cannot read, understand and fill in the questionnaire by themselves
2. Patients who idle their time away
3. Patients who are hospitalized
4. Patients who are undergoing treatment for dizziness, vertigo, presyncope, light-headedness which are likely due to chronic cerebral circulation impairment associated with sequelae of brain infarction
5. Patients whose dizziness, vertigo, presyncope, and light-headedness is definitely or likely caused by Meniere disease, vestibular neuronitis, benign paroxysmal positional vertigo, otitis media, or epilepsy
6. Patients whom the investigator judges are not suitable to participate in the study
Target sample size 2400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukito Shinohara
Organization KYOSAI Tachikawa HOSPITAL
Division name Neurology
Zip code
Address Nishiki Cho, 4-2-22, Tachikawa City, Tokyo, Japan, 151-0053
TEL 042-523-3131
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Shimokoube
Organization Kyorin Pharmaceutical Co., Ltd
Division name P.L.C. Management Department
Zip code
Address 5, Kanda Surugadai 2-Chome, Chiyoda-Ku, Tokyo 101-8311, Japan
TEL 03-3293-3422
Homepage URL
Email takashi.shimokoube@mb.kyorin-pharm.co.jp

Sponsor
Institute OASIS STUDY Research Group
Institute
Department

Funding Source
Organization Kyorin Pharmaceutical Co, Ltd
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

Other administrative information
Date of disclosure of the study information
2008 Year 05 Month 31 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 Completed
Date of protocol fixation
2005 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2005 Year 10 Month 01 Day
Last follow-up date
2007 Year 06 Month 01 Day
Date of closure to data entry
2007 Year 09 Month 01 Day
Date trial data considered complete
2007 Year 12 Month 01 Day
Date analysis concluded
2008 Year 10 Month 01 Day

Other
Other related information Period: 2005–2007
Observation time: baseline, 8 weeks, 24 weeks
Matters investigated:
1. QOL determination using SF-36 v2
2. Other matters:
Age, sex, brain infarction type, stroke severity (modified Rankin scale), side of stroke, complication, smoking, alcohol, dizziness-vertigo-presyncope-light headedness, combination medicine, subjective symptoms, psychic symptoms, rehabilitation, recurrence, evaluation of depression (Japan-Stroke Scale (JSS)-D)

Management information
Registered date
2005 Year 12 Month 07 Day
Last modified on
2007 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000370

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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