UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006633 |
|---|---|
| Receipt number | R000007831 |
| Scientific Title | Effect of antiplatelet agent on muscle cramps in patients with lumbar spinal canal stenosis and peripheral artery disease |
| Date of disclosure of the study information | 2011/11/01 |
| Last modified on | 2011/10/27 15:51:17 |
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Basic information
Public title
Effect of antiplatelet agent on muscle cramps in patients with lumbar spinal canal stenosis and peripheral artery disease
Acronym
Effect of antiplatelet agent on muscle cramps in patients with lumbar spinal canal stenosis and peripheral artery disease
Scientific Title
Effect of antiplatelet agent on muscle cramps in patients with lumbar spinal canal stenosis and peripheral artery disease
Scientific Title:Acronym
Effect of antiplatelet agent on muscle cramps in patients with lumbar spinal canal stenosis and peripheral artery disease
Region
| Japan |
Condition
Condition
Lumbar spinal canal stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study is conducted to evaluate the effect of Cilostazol on nocturnal muscle cramps in patients with lumbar spinal canal stenosis and peripheral artery disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective symptom of muscle cramps on 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
Continuous administration of 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Lumbar spinal canal stenosis
Administration of limaprost alfadex
Peripheral artery disease
Nocturnal muscle cramps
Patients who have given informed consent to participation in the study
Key exclusion criteria
Patients who are bleeding
Congestive heart failure
Patients with a history of hypersensitivity to any of the ingredients of this drug
Pregnant women or women having possibilities of being pregnant
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuho Yonezawa |
Organization
Juntendo University
Division name
Department of Orthopaedic Surgery
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8431 Japan
TEL
03-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ikuho Yonezawa |
Organization
Juntendo University
Division name
Department of Orthopaedic Surgery
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8431 Japan
TEL
03-3813-3111
Homepage URL
Sponsor or person
Institute
Juntendo University
Department of Orthopaedic Surgery
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
順天堂大学（東京都）/Juntendo University
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | 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
| 2011 | Year | 10 | Month | 31 | Day |
Last modified on
| 2011 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007831
