StrokeNCT00281034
OASIS STUDY Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS STUDY)
An observational study of Stroke, run by Kyorin Pharmaceutical Co.,Ltd at 1 site in Japan.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- How many people
- 2,069 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2005to Jul 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Univercity, Main hospital, general Hospital,0pen
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
Tachikawa, Tokyo, 190-8531
About this study
Official title: Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS Study)
- 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
Read the 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)
- Conditions
- Stroke
- Keywords
- brain infarction, SF-36, HRQOL, Japan, Post-stroke syndrome
- Medical subject headings
- Stroke, Brain Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OASIS Study Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
score of SF-36
Measured: 0, 8 week, 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2006 (estimated)
- Study startSep 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,069 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyorin Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Yukito Shinohara, Kyorin Pharmaceutical Co.,Ltd
- Investigators
- Yukito Shinohara, MD, Study chair, Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281034
- Sponsor's protocol ID
- OASIS-2005
- Other IDs
- oasis-2007
- Status last verified
- Apr 2012
- First submitted
- 23 Jan 2006
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20145390
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS Study)
- ClinicalTrials.gov ID
- NCT00281034
- Acronym / sponsor ID
- OASIS-2005
- Conditions
- Stroke
- Keywords
- brain infarction, SF-36, HRQOL, Japan, Post-stroke syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,069 participants (actual)
- Lead sponsor
- Kyorin Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Jul 2007 (actual)
- First posted
- 24 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OASIS Study Group | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Univercity, Main hospital, general Hospital,0pen
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
score of SF-36
Time frame: 0, 8 week, 24 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2012.
- Derived from this study: PubMed 20145390Shinohara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yukito Shinohara, MD study chair
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Kyorin Pharmaceutical Co.,Ltd at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score of SF-36 (time frame: 0, 8 week, 24 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00281034, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2012.