UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008776 |
|---|---|
| Receipt number | R000010312 |
| Scientific Title | Examination of the end time of limaprost treatment for lumbar spinal canal stenosis |
| Date of disclosure of the study information | 2012/08/27 |
| Last modified on | 2016/06/06 00:29:24 |
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Basic information
Public title
Examination of the end time of limaprost treatment for lumbar spinal canal stenosis
Acronym
Examination of the end time of limaprost treatment for lumbar spinal canal stenosis
Scientific Title
Examination of the end time of limaprost treatment for lumbar spinal canal stenosis
Scientific Title:Acronym
Examination of the end time of limaprost treatment for lumbar spinal canal stenosis
Region
| Japan |
Condition
Condition
Lumbar spinal canal stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of limaprost for lumbar spinal canal stenosis. In addition, to observe the change in symptoms in the presence or absence of continued administration limaprost .
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Distance and time of intermittent claudication(m,min)
Symptoms (pain, numbness)
Key secondary outcomes
JOA back pain evaluation questionnaire
Satisfaction of daily life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group to continue the limaprost administration after the onset of effect limaprost.
Interventions/Control_2
Group to discontinue treatment after the onset limaprost effect.
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
1.Acquired lumbar spinal canal stenosis
2.Patients presenting with intermittent claudication of attitude
3.Capable of giving informed consent
Key exclusion criteria
1.Patients with hypersensitivity to limaprost
2.Patients with bleeding tendency
3.Patients on anticoagulation therapy with other drugs
4.Patients with ASO
5.Patients suspected of being pregnant or pregnancy
6.Patients who were recognized unsuitable for this study by primary physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiko Hasegawa |
Organization
Hamamatsu University School of Medicine
Division name
Department of Orthopedics
Zip code
Address
431-3125 Handayama 1-20-1, Higashiku, Hamamatsushi,Shizuokaken, JAPAN
TEL
053-435-2299
hasetomo@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiko Hasegawa |
Organization
Hamamatsu University School of Medicine
Division name
Department of Orthopedics
Zip code
Address
431-3125 Handayama 1-20-1, Higashiku, Hamamatsushi,Shizuokaken, JAPAN
TEL
053-435-2299
Homepage URL
hasetomo@hama-med.ac.jp
Sponsor or person
Institute
Department of Orthopedics in Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
no
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
浜松医科大学医学部附属病院(静岡県)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 27 | 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 | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 27 | Day |
Last modified on
| 2016 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010312
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
