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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012918
Receipt No. 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

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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
Email 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
Email hashizum@wakayama-med.ac.jp

Sponsor
Institute Kansai LSS Forum
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015103

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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