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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004825
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute University of Tsukuba, Course of life-style related disorders donated by JA Ibaraki Public Welfare Federation
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005745

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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