UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012918 |
|---|---|
| Receipt number | R000015103 |
| Scientific Title | Long-term efficacy and safety of Limaprost for the treatment of Lumbar Spinal Stenosis |
| Date of disclosure of the study information | 2014/03/01 |
| Last modified on | 2014/01/22 10:37:40 |
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Basic information
Public title
Long-term efficacy and safety of Limaprost for the treatment of Lumbar Spinal Stenosis
Acronym
Long-term efficacy of Limaprost for LSS
Scientific Title
Long-term efficacy and safety of Limaprost for the treatment of Lumbar Spinal Stenosis
Scientific Title:Acronym
Long-term efficacy of Limaprost for LSS
Region
| Japan |
Condition
Condition
Lumbar Spinal Stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the long-term efficacy and safety of of Limaprost for the treatment of Lumbar Spinal Stenosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Zurich claudication questionnaire
Key secondary outcomes
Intermittent claudication
MOS-Short Form 12
Numeric Rating Scale(NRS) for pain and numbness intensity
Measurement of treatment satisfaction
Combined medicine and treatment
Surgery rate
EQ-5D
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are 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 alfadex(15 micro g/day), 1yrs.
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Lumbar spinal stenosis identified by Diagnostic tool and MRI
Key exclusion criteria
1) SLR positive
2) Current or history of critical limb ischemia
3) Uncontrolled DM
4) Diagnosis of RA
5) Clinically significant neurological or skeletal dysfunction
6)Unlikely to be compliant with protocol
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Munehito Yoshida |
Organization
Wakayama Medical University
Division name
Orthopaedic Surgery
Zip code
Address
811-1, Kimiidera, Wakayama City
TEL
073-441-0645
myoshida@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Hashizume |
Organization
Wakayama Medical University
Division name
Orthopaedic Surgery
Zip code
Address
811-1, Kimiidera, Wakayama City
TEL
073-441-0645
Homepage URL
hashizum@wakayama-med.ac.jp
Sponsor or person
Institute
Kansai LSS Forum
Institute
Department
Personal name
Funding Source
Organization
Department research fundsansai LSS Forum
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 03 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 22 | Day |
Last modified on
| 2014 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015103
| 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 |
