A Phase II Study of SI-613 in Patients with Knee Osteoarthritis

A Phase II Study of SI-613 in Patients with Knee Osteoarthritis - A Phase II Study of SI-613 in Patients with Knee Osteoarthritis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010167

Enrollment

120

Registered

2013-03-06

Start date

2013-03-21

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 high-dose group SI-613 low-dose 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
Efficacy Outcome: Change from baseline of WOMAC 3.1 Index (Pain)	—

Secondary

Measure	Time frame
Efficacy Outcome: WOMAC 3.1 Index Safety Outcome: Adverse events Clinical laboratory tests	—

Countries

Japan

Outcome results

None listed

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