UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008255 |
|---|---|
| Receipt number | R000009711 |
| Scientific Title | The efficacy of combination therapy of cilostazol and acetaminophen |
| Date of disclosure of the study information | 2012/06/26 |
| Last modified on | 2013/06/27 12:12:00 |
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Basic information
Public title
The efficacy of combination therapy of cilostazol and acetaminophen
Acronym
The efficacy of combination therapy of cilostazol and acetaminophen
Scientific Title
The efficacy of combination therapy of cilostazol and acetaminophen
Scientific Title:Acronym
The efficacy of combination therapy of cilostazol and acetaminophen
Region
| Japan |
Condition
Condition
Ischemic stroke
Classification by specialty
| Medicine in general | Cardiology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the frequency of headaches caused by cilostazol in different ways of dosage in patients with ischemic stroke
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
frequency of headache
Key secondary outcomes
Withdrawal of cilostazol due to adverse effect
Cardiovascular events
Pulse rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
monotherapy Group : Cilostazol 200 mg/day
Interventions/Control_2
Combination group : Cilostazol 200 mg/day BID + acetaminophen 800mg/day BID for the first 7 days ,followed by Cilostazol 200 mg/day BID + acetaminophen 400mg/dayBID for two weeks, and then, use of acetaminophen as-needed at the time of onset of headache for three months.
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)inpatients with ischemic stroke detected by X-ray CT scan or MRI (non-cardioembolic)
2)both new-onset or recurrent ischemic stroke are permitted
Key exclusion criteria
1. Patients with hemorrhage or bleeding tendency.
2. Patients with congestive heart failure.
3. Patients with a history allergy against cilostazol or other antiplatelets.
4. Pregnant or possibly pregnant
5. Patients with severe hepatic or renal dysfunction
6. Patients who are judged inappropriate for the study by the investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Johkura |
Organization
Hiratsuka Kyosai Hospital
Division name
Department of Neurology
Zip code
Address
9-11 Oiwake, Hiratsuka, Kanagawa 254-8502, Japan
TEL
0463-32-1950
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoo Yamamoto |
Organization
Hiratsuka Kyosai Hospital
Division name
Department of Neurology
Zip code
Address
9-11 Oiwake, Hiratsuka, Kanagawa 254-8502, Japan
TEL
0463-32-1950
Homepage URL
ryamamoto-tuk@umin.ac.jp
Sponsor or person
Institute
Hiratsuka Kyosai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
平塚共済病院 Hiratsuka Kyosai Hospital
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 26 | 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
| 2012 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 25 | Day |
Last modified on
| 2013 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009711
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
