A Phase II Study of SI-613 in Patients with Enthesopathy

A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding Study of SI-613 in Patients with Enthesopathy(Japan. Phase II)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223702

Enrollment

240

Registered

2017-11-06

Start date

2017-12-01

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

Enthesopathy

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: [Inclusion criteria for Lateral Epicondylitis] Patients who diagnosed with Lateral Epicondylitis [Inclusion criteria for Plantar facilitis] Patients who diagnosed with plantar fasciitis [Common inclusion criteria] Patients who have 6 weeks or longer symptoms Patients who are willing and able to complete daily pain diary during the study. Patients who are willing to discontinue pain medication, except for the investigational drug and rescue drug during the study.

Exclusion criteria

Exclusion criteria: Patients who received surgery to the target enthesopathy in the past. Patients who have pain which would interfere with the evaluation of the target enthesopathy.

Design outcomes

Primary

Measure	Time frame
efficacy Pain in Motion (NRS) Change from baseline over 4 weeks after administration	—

Secondary

Measure	Time frame
safety efficacy Pain in Rest, Average Pain, Tenderness, Induced Pain PREE-J(Lateral Epicondylitis), SAFE-Q(Plantar facilitis) Roles and Maudsley Score Patient Global Impression of Change, Clinical Global Impression of Change The incidence of adverse events	—

Countries

Japan

Outcome results

None listed

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