UMIN-CTR Clinical Trial

Basic information
Public title	Prospective clinical study of the therapeutic effects of prostaglandin in patients with combined lumbar spinal stenosis and arteriosclerosis obliterans showing intermittent claudication
Acronym	Clinical study on therapeutic effects of prostaglandin in patients with combined lumbar spinal stenosis and arteriosclerosis obliterans
Scientific Title	Prospective clinical study of the therapeutic effects of prostaglandin in patients with combined lumbar spinal stenosis and arteriosclerosis obliterans showing intermittent claudication
Scientific Title:Acronym	Clinical study on therapeutic effects of prostaglandin in patients with combined lumbar spinal stenosis and arteriosclerosis obliterans
Region	Japan

Condition
Condition	Patients with combined lumbar spinal stenosis and arteriosclerosis obliterans
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The prospective study is performed with the aim to evaluate the therapeutic effects of prostaglandin from the viewpoint of administration method and duration by administering the drug to patients with combined lumbar spinal stenosis and arteriosclerosis obliterans (peripheral arterial disease) who exhibit intermittent claudication, which tends to increase in aging society.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Japanese Orthopaedic Association (JOA) score
Key secondary outcomes	Age, sex, affected period, biochemical examination of blood, details of treatment (number and frequency of infusions, concomitant drug therapy, block therapy, and other conservative therapies), SF-36, VAS

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Prostaglandin for injection (alprostadil) group: 60 mcg of prostaglandin for injection is intravenously administered once a week or more. This therapy is repeated 10 times or more.
Interventions/Control_2	Ripple injection (alprostadil Injection) group: 10 mcg of ripple injection is administered intravenously once a week or more. This treatment is repeated 10 times or more.
Interventions/Control_3	Conventional treatment group
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	The subjects are patients who meet all of the following inclusion criteria and are able to provide informed consent. 1) Male and female patients aged 20 years or older. 2) Patients who are diagnosed with lumbar spinal stenosis based on X-ray and MRI findings and are undergoing conservative treatment. 3) Patients who are diagnosed with arteriosclerosis obliterans (peripheral arterial disease) Fontaine classification I or II. 4) Patients who understand the objectives of this study and provide informed consent.
Key exclusion criteria	The patients who meet any of the following exclusion criteria are excluded. 1) Patients who have ethical difficulties due to special consideration required for them or their family. 2) Patients with diabetes, chronic renal failure, etc. who are suspected to have a complication of peripheral nerve disorder or circulatory disorder. 3) Patients who are receiving administration of anticoagulant, etc. 4) Patients who have a history of surgical treatment for the spine/spinal cord. 5) Patients who have problematic infection. 6) Patients who do not understand the objectives of this study.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name MASATO SATO,M.D.,Ph.D.
Organization	Tokai University School of Medicine
Division name	Department of Orthopaedic Surgery
Zip code
Address	143,Shimokasuya,Isehara,Kanagawa,259-1193,Japan
TEL	0463-93-1121
Email

Public contact
Name of contact person	1st name Middle name Last name MASATO SATO,M.D.,Ph.D.
Organization	Tokai University School of Medicine
Division name	Department of Orthopaedic Surgery
Zip code
Address	143,Shimokasuya,Isehara,Kanagawa,259-1193,Japan
TEL	0463-93-1121
Homepage URL
Email

Sponsor
Institute	Tokai University Hospital Department of Orthopaedic Surgery
Institute
Department

Funding Source
Organization	Tokai University Hospital Department of Orthopaedic Surgery
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

Other administrative information
Date of disclosure of the study information	2011 Year 07 Month 12 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	2010 Year 04 Month 12 Day
Date of IRB	2010 Year 11 Month 04 Day
Anticipated trial start date	2010 Year 11 Month 04 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 07 Month 11 Day
Last modified on	2019 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007018