UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010167 |
|---|---|
| Receipt number | R000011908 |
| Scientific Title | A Phase II Study of SI-613 in Patients with Knee Osteoarthritis |
| Date of disclosure of the study information | 2013/03/06 |
| Last modified on | 2014/01/28 16:12:44 |
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Basic information
Public title
A Phase II Study of SI-613 in Patients with Knee Osteoarthritis
Acronym
A Phase II Study of SI-613 in Patients with Knee Osteoarthritis
Scientific Title
A Phase II Study of SI-613 in Patients with Knee Osteoarthritis
Scientific Title:Acronym
A Phase II Study of SI-613 in Patients with Knee Osteoarthritis
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study objectives are to evaluate the efficacy and safety of SI-613 exploratively in patients with Knee Osteoarthritis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Efficacy Outcome:
Change from baseline of WOMAC 3.1 Index (Pain)
Key secondary outcomes
Efficacy Outcome:
WOMAC 3.1 Index
Safety Outcome:
Adverse events
Clinical laboratory tests
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Placebo group
Interventions/Control_2
SI-613 high-dose group
Interventions/Control_3
SI-613 low-dose group
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Patients with a diagnosis of Knee Osteoarthritis according to ACR criteria
-Patients with radiographic evidence of Kellgren and Lawrence grade 2 or 3
Key exclusion criteria
-Patients with secondary OA resulting from trauma or other diseases
-Patients with risk of infection in the area of the injection site due to skin disease or infection
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Nishida |
Organization
Nagoya University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
65 Tsurumai, Showa, Nagoya, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
SEIKAGAKU CORPORATION
Division name
Clinical Development Dept. Research & Development Div.
Zip code
Address
Marunouchi 1-chome, Chiyoda-ku, Tokyo, Japan
TEL
Homepage URL
Sponsor or person
Institute
SEIKAGAKU CORPORATION
Institute
Department
Personal name
Funding Source
Organization
SEIKAGAKU CORPORATION
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2013 | Year | 03 | 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
| 2013 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 21 | 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
| 2013 | Year | 03 | Month | 05 | Day |
Last modified on
| 2014 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011908
| 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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