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A confirmatory study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis)

A confirmatory study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis) - A confirmatory study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010982
Enrollment
540
Registered
2013-06-21
Start date
2013-05-31
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

Placebo SI-657

Sponsors

KAKEN PHARMACEUTICAL CO., LTD/SEIKAGAKU CORPORATION
Lead Sponsor

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 12 weeks or longer symptoms 3.Patients between 16 and 75 years old.

Exclusion criteria

Exclusion criteria: 1.Patients who received localized injection at the involved limb or any steroid topical treatment within 2 weeks before administration. 2.Patients with acute symptoms (i.e., sprain, injury or surgery) at the affected site. 3.Patients with infectious risk at administration due to their skin disease or infection. 4.Patients, the investigator (or the subinvestigator) considers, inappropriate for entry into the trial.

Design outcomes

Primary

MeasureTime frame
Change of Visual Analogue Scale (VAS) of pain at final evaluation.

Secondary

MeasureTime frame
Efficacy Outcomes -Roles and Maudsley score Safety Outcomes -Adverse events -Laboratory tests

Countries

Japan

Outcome results

None listed

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