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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003367
Receipt No. 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 2010/03/24

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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
Middle name
Last name Takeo Nagura
Organization Keio University, School of Medicine
Division name Orthopedic Surgery
Zip code
Address 35 Shinanomachi, Shinjyuku, Tokyo
TEL 0353633812
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University, School fo Medicine
Division name Orthopedic Surgery
Zip code
Address
TEL
Homepage URL
Email nagura@sc.itc.keio.ac.jp

Sponsor
Institute Keio University, Shool of Medicine
Institute
Department

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
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
2010 Year 03 Month 24 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2009 Year 11 Month 03 Day
Date of IRB
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
2010 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004094

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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