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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name