UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II Study of SI-613 in Patients with Knee Osteoarthritis (repeat-dose study)
Title of the study (Brief title)	A Phase II Study of SI-613 in Patients with Knee Osteoarthritis (repeat-dose study)
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 repeated injection of SI-613 in patients with knee osteoarthritis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change from baseline in following outcomes during 12 weeks -WOMAC 3.1 Index (Pain) -Knee pain -50-foot walk test
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Placebo group
Interventions/Control_2	SI-613 group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	160

Research contact person
Name of lead principal investigator	Yosuke Funakoshi
Organization	SEIKAGAKU CORPORATION
Division name	Clinical Development Dept. Research & Development Div.
Address	6-1, Marunouchi 1-chome, Chiyoda-ku, Tokyo 100-0005, Japan
TEL	03-5220-8593
Email	yosuke.funakoshi@seikagaku.co.jp

Public contact
Name of contact person	Kazuyuki Kano
Organization	SEIKAGAKU CORPORATION
Division name	Clinical Development Dept. Research & Development Div.
Address	6-1, Marunouchi 1-chome, Chiyoda-ku, Tokyo 100-0005, Japan
TEL	03-5220-8593
Homepage URL
Email	kazuyuki.kano@seikagaku.co.jp

Sponsor
Institute	SEIKAGAKU CORPORATION
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 12 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 10 Day
Anticipated trial start date	2014 Year 12 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 05 Day
Last modified on	2016 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018453