UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003367 |
|---|---|
| Receipt number | R000004094 |
| Scientific Title | Effect of drug on intermittent claudication with lumbar canal stenosis |
| Date of disclosure of the study information | 2010/03/24 |
| Last modified on | 2021/12/13 16:51:50 |
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Basic information
Public title
Effect of drug on intermittent claudication with lumbar canal stenosis
Acronym
Drug effect on intermittent claudication
Scientific Title
Effect of drug on intermittent claudication with lumbar canal stenosis
Scientific Title:Acronym
Drug effect on intermittent claudication
Region
| Japan |
Condition
Condition
lumbar canal stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate drug effect on claudication with lumbar disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Xray, MRI, JOA score, VAS, Gait parameters
Key secondary outcomes
Walk distance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
anti platelet agent
Interventions/Control_2
non steroid anti inflamatory drug
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
lumbar degeretive disease
intermittent claudication within 30 min
without ASO
Key exclusion criteria
epidural block within 1 month
bleeding
severe heart, hepatic or renal failure
drug allegy
contraindicatio for attendance
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nagura |
| Middle name | |
| Last name | Takeo |
Organization
Keio University, School of Medicine
Division name
Orthopedic Surgery
Zip code
1608582
Address
35 Shinanomachi, Shinjyuku, Tokyo
TEL
0353633812
nagura@z8.keio.jp
Public contact
Name of contact person
| 1st name | Nagura |
| Middle name | |
| Last name | Takeo |
Organization
Keio University, School fo Medicine
Division name
Orthopedic Surgery
Zip code
1608582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
0353633812
Homepage URL
nagura@z8.keio.jp
Sponsor or person
Institute
Keio University, Shool of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University, School of Medicine, Orthopedic 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
IRB Comittee, Keio University
Address
35 Shinanomachi, Shinjuku, Tokyo
Tel
0353633812
nagura@z8.keio.jp
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
| 2010 | Year | 03 | Month | 24 | Day |
Related information
URL releasing protocol
none
Publication of results
Partially published
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
0
Results
closed
Results date posted
| 2021 | Year | 12 | Month | 13 | Day |
Results Delayed
Results Delay Reason
No possible patient
Date of the first journal publication of results
Baseline Characteristics
LCS patient
Participant flow
LCS patient with claudication
Adverse events
None
Outcome measures
Gait Distance
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2009 | Year | 11 | Month | 03 | Day |
Date of IRB
| 2010 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 24 | Day |
Last modified on
| 2021 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004094
