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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007419
Receipt No. R000008738
Scientific Title A Prospective, Randomized, Multicenter Trial of Pregabalin and Celecoxib for Lumbar Spinal Stenosis
Date of disclosure of the study information 2012/04/01
Last modified on 2014/09/01

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Basic information
Public title A Prospective, Randomized, Multicenter Trial of Pregabalin and Celecoxib for Lumbar Spinal Stenosis
Acronym A Prospective, Randomized, Multicenter Trial of Pregabalin and Celecoxib for Lumbar Spinal Stenosis
Scientific Title A Prospective, Randomized, Multicenter Trial of Pregabalin and Celecoxib for Lumbar Spinal Stenosis
Scientific Title:Acronym A Prospective, Randomized, Multicenter Trial of Pregabalin and Celecoxib for Lumbar Spinal Stenosis
Region
Japan

Condition
Condition Lumbar Spinal Stenosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effectiveness of Pregabalin and Celecoxib for the pain and ADL of lumbar spinal stenosis patinets
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The recovery of pain and ADL four weeks after the administration
Key secondary outcomes The recovory of NRS, ODI, SF-36 score four weeks after the administration

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Celecoxib
Interventions/Control_2 Pregabalin
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
90 years-old >
Gender Male and Female
Key inclusion criteria LSS patients who represent 7 points and over in LSS diagnosis tool
LSS patients who represents 6 points and under in LSS diagnosis tool but diagnosed by MRI
Conform to the combined drug standard
NRS 4 points and over
At the age 50 to 89
Using NSAIDs except Celecoxib over two weeks
Key exclusion criteria Arteriosclerosis obliterans
Diabetic neuropathy
Anterior tibial muscle MMT 3 and below
Ineffectiveness of epidural block over 3 times in a month
Vesicorectal disturbance
Heart failure
Herniated disc disase
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Maeno
Organization Kobe university Graduate School of Medicine
Division name Department of Orthopedic Surgery
Zip code
Address 7-5-2 Kusunoki-cyo Cyuou-ku Kobe-city Hyogo-prefecture Japan
TEL 078-382-5985
Email takada-t@hokuto-hp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Maeno
Organization Kobe university Graduate School of Medicine
Division name Department of Orthopedic Surgery
Zip code
Address 7-5-2 Kusunoki-cyo Cyuou-ku Kobe-city Hyogo-prefecture Japan
TEL 078-382-5985
Homepage URL
Email takada-t@hokuto-hp.or.jp

Sponsor
Institute Department of Orthopedic Surgery Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Orthopedic Surgery Kobe University Graduate School of Medicine
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
2012 Year 04 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
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 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
2012 Year 03 Month 01 Day
Last modified on
2014 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008738

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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