UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007419 |
|---|---|
| Receipt number | 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 09:29:22 |
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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
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
takada-t@hokuto-hp.or.jp
Sponsor or person
Institute
Department of Orthopedic Surgery Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008738
| 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 |
