UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029709 |
|---|---|
| Receipt number | R000033950 |
| Scientific Title | Conparative study of usefulness LOQOA tape and existing treatment that is combination of a patch and an oral medication of NSAIDs for osteoarhthritis of the knee |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2019/05/02 15:33:20 |
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Basic information
Public title
Conparative study of usefulness LOQOA tape and existing treatment that is combination of a patch and an oral medication of NSAIDs for osteoarhthritis of the knee
Acronym
The analysis of usefulness of LOQOA tape for osteoarthritis of the knee
Scientific Title
Conparative study of usefulness LOQOA tape and existing treatment that is combination of a patch and an oral medication of NSAIDs for osteoarhthritis of the knee
Scientific Title:Acronym
The analysis of usefulness of LOQOA tape for osteoarthritis of the knee
Region
| Japan |
Condition
Condition
osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare efficacy and safety of LOQOA tape and a combination of a patch and an oral medication of NSAIDs in knee osteoarthritis patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of change in Visual Analog Scale (VAS) after 4 weekes treatment
Key secondary outcomes
The amount of change in Visual Analog Scale (VAS) after 2 weekes treatment
The amount of change in Knee Injury and Osteoarthritis Outcome Score (KOOS), JOA score and 2-step test after 2 and 4 weekes treatment
The amount of change in Locomo 25 and EQ-5D after 4 weekes treatment
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
LOQOA tape is put for four weeks.
Interventions/Control_2
NSAIDs are administered in addition to putting existing poultices for four 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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients with the knee to be evaluated at KL classification grade 2-3
2.Patients receiving no treatment for gonarthrosis to be evaluated within 14 days before starting the study (although treatment by taking medicine only when necessary will be allowed)
3.Patients with a standing VAS of 40 mm or higher at the knee to be evaluated when starting the study
4.Patients with no pain symptom on the other (non-evaluated) knee which would affect the evaluation
5.Patients who can receive and understand explanation on the study, and give a written consent by his/her own previously, upon participating the study
Key exclusion criteria
1.Patients who have received joint replacement or highly restricted range of motion (extension/flex) on the knee to be evaluated
2.Patients with other knee pain diseases, diseases impairing ADL, neuropsychiatric diseases, dementia, severe hypertension, peptic ulcer, serious diseases, or skin diseases
3.Patients with a history of dermatitis requiring treatment with patches;
4.Patients with a history of allergy to NSAIDs
5.Patients who have or have had aspirin asthma (asthma attack induced by NSAIDs, etc)
6.Women who are pregnant or possibly pregnant, nursing, or planning to be pregnant, or men who wish his partner to be pregnant, during the study period
7.Other patients applicable to contraindication according to the current product labelling of the study drug.
Target sample size
216
Research contact person
Name of lead principal investigator
| 1st name | Shizuka |
| Middle name | |
| Last name | Sasaki |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, Aomori 036-8562, Japan
TEL
0172-39-5083
shizuka@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shizuka |
| Middle name | |
| Last name | Sasaki |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, Aomori 036-8562, Japan
TEL
0172-39-5083
Homepage URL
shizuka@hirosaki-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Taisho Toyama Pharmaceutical Co., Ltd.
TEIJIN PHARMA LIMITED.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical Research, Hirosaki University
Address
Hon-cho 53, Hirosaki, Aomori
Tel
0172-39-5294
ckcenta@hirosaki-u.ac.jp
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
| 2017 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 26 | 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
| 2017 | Year | 10 | Month | 25 | Day |
Last modified on
| 2019 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033950
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| Registered date | File name |
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