UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005959 |
|---|---|
| Receipt number | R000007018 |
| Scientific Title | Prospective clinical study of the therapeutic effects of prostaglandin in patients with combined lumbar spinal stenosis and arteriosclerosis obliterans showing intermittent claudication |
| Date of disclosure of the study information | 2011/07/12 |
| Last modified on | 2019/08/06 16:04:15 |
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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
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
Sponsor or person
Institute
Tokai University Hospital
Department of Orthopaedic Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007018
