Multicenter and Open-label Phase IIa Study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis)

Multicenter and Open-label Phase IIa Study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis) - Multicenter and Open-label Phase IIa Study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006014

Enrollment

Registered

2011-07-22

Start date

2011-06-01

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 (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis)

Interventions

SI-657

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed with enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis) 2.Patients with 4 weeks or longer symptoms 3.Patients between 20 and 75 years old.

Exclusion criteria

Exclusion criteria: 1.Patients who received localized injection at the involved site or any steroid topical treatment within 2 weeks before administration. 2.Exclusion criteria for each disease are below. - Lateral Epicondylitis: Patients with more severe pain due to complications within the affected upper limb than lateral epicondylitis. - Patellar Tendinitis: Patients with more severe pain due to complications within the affected lower leg than patellar tendinitis. - Achilles Tendinitis, Plantar Fasciitis: Patients with acute symptoms (i.e., sprain, injury or surgery) at the affected foot. 3.Patients with rheumatic joint diseases. 4.Patients with infectious risk at administration due to their skin disease or infection. 5.Patients, the investigator (or the subinvestigator) considers, inappropriate for entry into the trial.

Design outcomes

Primary

Measure	Time frame
1.Safety Outcomes - Adverse Events - Laboratory tests 2.Maximum injectable volume at each site	—

Secondary

Measure	Time frame
Efficacy Outcomes - Visual Analogue Scale of pain - Roles and Maudsley score	—

Countries

Japan

Contacts

Public ContactHiroyuki Hosokawa

SEIKAGAKU CORPORATION Clinical Development Dept. Research & Development Div.

03-5220-8593

Outcome results

None listed

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