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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006633
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Juntendo University
Department of Orthopaedic Surgery
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007831

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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