A Dose-finding Phase II Study of SI-657 in Patients with Enthesopathy (Plantar Fasciitis)

A Dose-finding Phase II Study of SI-657 in Patients with Enthesopathy (Plantar Fasciitis) - A Dose-finding Phase II Study of SI-657 in Patients with Enthesopathy (Plantar Fasciitis)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007257

Enrollment

180

Registered

2012-02-10

Start date

2012-01-21

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

Enthesopathy (Plantar Fasciitis)

Interventions

Placebo group SI-657 high-dose group SI-657 low-dose group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients diagnosed with plantar fasciitis -Patients with 12 weeks or longer symptoms -Patients between 20 and 75 years old

Exclusion criteria

Exclusion criteria: -Patients who received local injection or steroid topical treatment at the leg affected with plantar faciitis within 2 weeks before the first administration. -Patients with acute symptoms (i.e., sprain, injury or surgery) at the affected foot. -Patients with infectious risk at the administration site due to their skin disease or infection.

Design outcomes

Primary

Measure	Time frame
Efficacy Outcome Change of Visual Analogue Scale (VAS) of pain at final evaluation.	—

Secondary

Measure	Time frame
Efficacy Outcomes -Roles and Maudsley score Safety Outcomes -Adverse events -Laboratory tests	—

Countries

Japan

Contacts

Public ContactToshiyuki Yorozuya/Hiroyuki Hosokawa

KAKEN PHARMACEUTICAL CO., LTD/SEIKAGAKU CORPORATION Clinical Development Department/Clinical Development Dept. Research & Development Div.

03-5977-5111(03-5220-8593)

Outcome results

None listed

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