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

Phase 2

• Conditions: Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis)

• Registration Number: JPRN-UMIN000006014
• Lead Sponsor: SEIKAGAKU CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Safety Outcomes - Adverse Events - Laboratory tests 2.Maximum injectable volume at each site

Secondary Outcome Measures

Name	Time	Method
Efficacy Outcomes - Visual Analogue Scale of pain - Roles and Maudsley score