UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004825 |
|---|---|
| Receipt number | R000005745 |
| Scientific Title | A randomized comparative study of Celecoxib and Limaprost alfadex on the patients with lumber spinal stenosis for the effectiveness for symptoms and QOL |
| Date of disclosure of the study information | 2011/01/06 |
| Last modified on | 2014/01/06 09:13:04 |
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Basic information
Public title
A randomized comparative study of Celecoxib and Limaprost alfadex on the patients with lumber spinal stenosis for the effectiveness for symptoms and QOL
Acronym
A randomized comparative study of medications for patients with lumber spinal stenosis
Scientific Title
A randomized comparative study of Celecoxib and Limaprost alfadex on the patients with lumber spinal stenosis for the effectiveness for symptoms and QOL
Scientific Title:Acronym
A randomized comparative study of medications for patients with lumber 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 of Celecoxib and Limaprost alfadex on the patients with lumber spinal stenosis for the effectiveness for symptoms and QOL
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Zurich claudication questionnaire
Key secondary outcomes
6-minute walk test
JOA back pain evaluation questionnaire
SF-36
Lumber extension test
Safety: adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
15ug/day Limaprost arfadex for 8 weeks
Interventions/Control_2
200mg/day Celecoxib for 8 weeks
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Above seven point of the score for a diagnostic support tool for lumbar spinal stenosis
2.Radiologic diagnosis of lumbar spinal stenosis
3.Capable of giving informed consent
Key exclusion criteria
1.Congenital lumbar spinal stenosis
2.Operation for lumbar spinal stenosis before three months
3.Indication for operation
4.Taking NSAIDs, Limaprost and Steroids before a week
5.Exclusion criteria
a)ASO and below 0.9 of ABI
b)Cerebral infarction
c)Gait disturbance with Knee and hip osteoarthritis
d)Diabetes (HbA1c>10% or diabetic neuropathy)
6. Severe low back pain and vertebral body fracture
7. Severe systemic past history such as heart, liver or kidney disease
8. Peptic ulcer
9. Severe abnormal symptom of blood
10. Pregnant or intend to become pregnant during the study period
11. History of hypersensitivity to Limaprost, celecoxib and sulfonamide
12. Aspirin-induced asthma
13. Patients who were recognized unsuitable for this study by primary physician
Target sample size
134
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naotaka Mamizuka |
Organization
Mito Medical Center University of Tsukuba
Division name
Orthopedics
Zip code
Address
3-2-7, Miyamachi, Mito, Ibaraki
TEL
029-231-2371
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Hashimoto |
Organization
University of Tsukuba
Division name
Tsukuba Critical Path Research and Education Integrated Leading Center, Course of life-style related
Zip code
Address
1-1-1, Tennodai, Tsukuba, Ibaraki
TEL
029-853-3076
Homepage URL
Sponsor or person
Institute
University of Tsukuba, Course of life-style related disorders donated by JA Ibaraki Public Welfare Federation
Institute
Department
Personal name
Funding Source
Organization
JA Ibaraki Public Welfare Federation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Mito Kyodo Hospital
Name of secondary funder(s)
General Incorporated Association Orthopedics Network Tsukuba
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
水戸協同病院（茨城県）、小松整形外科医院（茨城県）、なめがた地域総合病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 06 | 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
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | 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
| 2011 | Year | 01 | Month | 06 | Day |
Last modified on
| 2014 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005745
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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