UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006619 |
|---|---|
| Receipt number | R000007828 |
| Scientific Title | Influence of the home-based excecise of the patient with knee osteoarthritis by Cox2-Inhibitoror and home-based exercise combination therapy |
| Date of disclosure of the study information | 2011/10/27 |
| Last modified on | 2014/10/27 11:56:03 |
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Basic information
Public title
Influence of the home-based excecise of the patient with knee osteoarthritis by Cox2-Inhibitoror and home-based exercise combination therapy
Acronym
Influence of the home-based excecise of the patient with knee osteoarthritis by Cox2-Inhibitoror and home-based exercise combination therapy
Scientific Title
Influence of the home-based excecise of the patient with knee osteoarthritis by Cox2-Inhibitoror and home-based exercise combination therapy
Scientific Title:Acronym
Influence of the home-based excecise of the patient with knee osteoarthritis by Cox2-Inhibitoror and home-based exercise combination therapy
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy compared home-based excercise and the combination of home-based excercise and celexoxib
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
JOA score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
JKOM score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
Home based excecise and celecoxib
Interventions/Control_2
Home-based excecise
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
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
The patient who has daiagnosed as knee osteoarthritis with Kellgren & Lawrence grade of I to III by X-ray imaging.
Aged 50 to 69 years of age at the time of enrollment
Written consent for participation in the study
Key exclusion criteria
1)History of hypersesitivity to any components of the investigational products to be used int this research study
2)Women who are pregnant, breastfeeding, or plannning to become pregnant during the study period
3)Serious renal, hepatic, and/or cardiovascular disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | YUJI TAKAZAWA |
Organization
Juntendo University
Division name
Dept. of Orthopaedics
Zip code
Address
2-1-2, Hongou, Bukyo-ku, Tokyo, JAPAN
TEL
03-3813-3111
takayuuji@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YUJI TAKAZAWA |
Organization
Juntendo University
Division name
Dept. of Orthopaedics
Zip code
Address
2-1-2, Hongou, Bukyo-ku, Tokyo, JAPAN
TEL
03-3813-3111
Homepage URL
takayuuji@aol.com
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 10 | Month | 27 | 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
| 2011 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | 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 | 10 | Month | 27 | Day |
Last modified on
| 2014 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007828
| 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 |
