UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Cilostazol to a patient who merges lumbar spinal canal stenosis and arteriosclerosis obliterans.
Title of the study (Brief title)	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	Tomohiko Hasegawa
Organization	Hamamatsu University School of Medicine
Division name	Department of Orthopedic surgery
Address	1-20-1, Handayama, Higashi-Ku, Hamamatsu city, Shizuoka
TEL	053-435-2299
Email	hasetomo@hama-med.ac.jp

Public contact
Name of contact person	Hideyuki Arima
Organization	Hamamatsu University School of Medicine
Division name	Department of orthopedic surgery
Address	1-20-1 Handayama HIgaashi-ku Hamamatsu city Shizuoka
TEL	053-435-2299
Homepage URL
Email	arihidee@yahoo.co.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011705