A Phase II Study of SI-613 in Patients with Knee Osteoarthritis (repeat-dose study)

A Phase II Study of SI-613 in Patients with Knee Osteoarthritis (repeat-dose study) - A Phase II Study of SI-613 in Patients with Knee Osteoarthritis (repeat-dose study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015858

Enrollment

160

Registered

2014-12-11

Start date

2014-12-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Interventions

Placebo group SI-613 group

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in following outcomes during 12 weeks -WOMAC 3.1 Index (Pain) -Knee pain -50-foot walk test	—

Countries

Japan

Contacts

Public ContactKazuyuki Kano

SEIKAGAKU CORPORATION Clinical Development Dept. Research & Development Div.

kazuyuki.kano@seikagaku.co.jp03-5220-8593

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026