Status:
COMPLETED
OASIS STUDY Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS STUDY)
Lead Sponsor:
Kyorin Pharmaceutical Co.,Ltd
Conditions:
Stroke
Eligibility:
All Genders
Brief Summary
1. To survey the health-related quality of life using the SF-36v2 score of patients with chronic brain infarction in Japan 2. Chronic brain infarction in Japan is better than EU/USA
Detailed Description
Period:2005-2007 Observation Time:baseline, 8week, 24week matters investigated: 1. QOL determination using SF-36 v2 2. Age, sex, brain infarction type, stroke severity (modified Rankin scale), side...
Eligibility Criteria
Inclusion
- Patients whose last attack occurred more than 1 month ago
- Outpatients (including hospitalization for rehabilitation)
- Japanese nationality
- Patients who consented to participate in this study
- 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
Exclusion
- Patients who cannot read, understand and fill in the questionnaire by themselves
- Patients who idle their time away
- Patients who are hospitalized
- 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
- 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 epilepsy6. Patients whom the investigator judges are not suitable to participate in the study
Key Trial Info
Start Date :
September 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
2069 Patients enrolled
Trial Details
Trial ID
NCT00281034
Start Date
September 1 2005
End Date
July 1 2007
Last Update
April 12 2012
Active Locations (1)
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1
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
Tachikawa, Tokyo, Japan, 190-8531