Long Term Follow-up Study of SI-613 in Patients with OA

Long Term Follow-up Study to Evaluate the Safety of Repeated Intra-Articular Injection of SI-613 in Patients with Osteoarthritis(Japan. Phase III)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223799

Enrollment

160

Registered

2018-02-06

Start date

2018-02-28

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

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: Subject who has diagnosed with OA by X-ray and observed a deformability change at the time of screening. Subject who has OA pain in the target joint which is longer than or equal to 12 weeks prior to the time of informed consent.

Exclusion criteria

Exclusion criteria: Subjects who has significant joint deformation such as a large osteophyte or remarkable narrowing of the joint space. Subject who is difficult to continue outpatient during informed concent and 52week.

Design outcomes

Primary

Measure	Time frame
safety The incidence of adverse events Target joint examination X-ray imaging test	—

Secondary

Measure	Time frame
safety efficacy Target joint pain WOMAC (knee and hip joints) Shoulder 36 (shoulder joint) PREE-J (elbow joint) SAFE-Q (ankle joint)	—

Countries

Japan

Outcome results

None listed

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