UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000293 |
|---|---|
| Receipt number | 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 08:27:43 |
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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
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
takashi.shimokoube@mb.kyorin-pharm.co.jp
Sponsor or person
Institute
OASIS STUDY Research Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000370
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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