A Phase III Study of SI-613 in Patients with Knee Osteoarthritis (confirmatory study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223482

Enrollment

440

Registered

2017-03-14

Start date

2017-04-11

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

investigational material(s) Generic name etc : SI-613 INN of investigational material : diclofenac etalhyaluronate Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Admini

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of osteoarthritis of the knee according to American College of Rheumatology criteria at the time of screening. Kellgren-Lawrence score grade 2 or 3 in an Antero-posterior weight-bearing x-ray of the target knee joint in the standing position taken at the time of screening. Subjects who are willing to discontinue pain medication except as permitted per protocol from the start date of screening to the end of Week 24 after the first injection (using acetaminophen as a rescue medication is permitted for breakthrough pain control).

Exclusion criteria

Exclusion criteria: Secondary OA resulting from trauma or the other diseases in the target knee Subjects who have pain in lower extremity other than knee OA if it would interfere with the evaluation of the target knee or have OA of the hip or ankle at screening and Week 0 before injection.

Design outcomes

Primary

Measure	Time frame
efficacy WOMAC 3.1 Index (Pain) Change from baseline in WOMAC 3.1 Index (Pain) during 12 weeks	—

Secondary

Measure	Time frame
safety efficacy WOMAC total score 50-foot walk test The incidence of adverse events	—

Countries

Japan

Outcome results

None listed

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