OASIS STUDY Outcome Assessment Using SF-36 v2 in Stroke P... | NCT00281034

Studies
OASIS STUDY Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS STUDY)

NCT00281034

Sponsor

Kyorin Pharmaceutical Co.,Ltd

Status

Completed

Last Update Posted

Apr 12, 2012Estimated

Enrollment

2,069Actual

Phase

Not provided

Conditions

Stroke

Interventions

Not provided

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
oasis-2007

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Jul 2007Actual

First Submitted Date

Jan 23, 2006

First Submission Date that Met QC Criteria

Jan 23, 2006

First Posted Date

Jan 24, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2012

Last Update Posted Date

Apr 12, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To survey the health-related quality of life using the SF-36v2 score of patients with chronic brain infarction in Japan
Chronic brain infarction in Japan is better than EU/USA

Detailed Description

Period:2005-2007

Observation Time:baseline, 8week, 24week

matters investigated:

QOL determination using SF-36 v2
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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,069Actual

Label	Type	Description	Intervention Names
OASIS Study Group

Measure	Description	Time Frame
score of SF-36		0, 8 week, 24 week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Univercity, Main hospital, general Hospital,0pen

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yukito Shinohara, MD	Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital		Tachikawa	Tokyo	190-8531	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20145390	Derived	Shinohara Y; OASIS Study Group. Factors affecting health-related quality of life assessed with the SF-36v2 health survey in outpatients with chronic-stage ischemic stroke in Japan--cross-sectional analysis of the OASIS study. Cerebrovasc Dis. 2010;29(4):361-71. doi: 10.1159/000281834. Epub 2010 Feb 9.

ID	Term
D020521	Stroke
D020520	Brain Infarction

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases