UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009997 |
|---|---|
| Receipt number | R000011705 |
| Scientific Title | Effect of Cilostazol to a patient who merges lumbar spinal canal stenosis and arteriosclerosis obliterans. |
| Date of disclosure of the study information | 2013/02/11 |
| Last modified on | 2017/05/08 09:08:06 |
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Basic information
Public title
Effect of Cilostazol to a patient who merges lumbar spinal canal stenosis and arteriosclerosis obliterans.
Acronym
Effect of Cilostazol to a patient who merges lumbar spinal canal stenosis and arteriosclerosis obliterans.
Scientific Title
Effect of Cilostazol to a patient who merges lumbar spinal canal stenosis and arteriosclerosis obliterans.
Scientific Title:Acronym
Effect of Cilostazol to a patient who merges lumbar spinal canal stenosis and arteriosclerosis obliterans.
Region
| Japan |
Condition
Condition
lumbar spinal canal stenosis
arteriosclerosis obliterans
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research was to identify the validity of a patient who merges lumbar spinal canal stenosis and arteriosclerosis obliterans.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analog Scale
Japanese Orthopaedic Association Score
Japanese Orthopaedic Association Back Pain Evaluation Questionnaire
Walking Impairment Questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
limaprost
cilostazol
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1, The patient diagnosed as spinal canal stenosis by the diagnostic support tool and magnetic resonance image.
2, The patient diagnosed as arteriosclerosis obliterans by ABI (<1.0) or TPI (<=0.6)
The patient who was able to acquire the approve by letter to the work preinitiation
Key exclusion criteria
1, The contraindication patient of a cilostazol .
2, The patient who cannot understand the main point of this research
3, The patient more than 3 degree of Fontaine classification
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiko Hasegawa |
Organization
Hamamatsu University School of Medicine
Division name
Department of Orthopedic surgery
Zip code
Address
1-20-1, Handayama, Higashi-Ku, Hamamatsu city, Shizuoka
TEL
053-435-2299
hasetomo@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Arima |
Organization
Hamamatsu University School of Medicine
Division name
Department of orthopedic surgery
Zip code
Address
1-20-1 Handayama HIgaashi-ku Hamamatsu city Shizuoka
TEL
053-435-2299
Homepage URL
arihidee@yahoo.co.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 11 | 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
| 2013 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 08 | Day |
Last modified on
| 2017 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011705
| 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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| Registered date | File name |
