A Dose-finding Phase II Study of SI-657 in Patients with Enthesopathy (Plantar Fasciitis)
Phase 2
- Conditions
- Enthesopathy (Plantar Fasciitis)
- Registration Number
- JPRN-UMIN000007257
- Lead Sponsor
- KAKEN PHARMACEUTICAL CO., LTD/SEIKAGAKU CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy Outcome Change of Visual Analogue Scale (VAS) of pain at final evaluation.
- Secondary Outcome Measures
Name Time Method Efficacy Outcomes -Roles and Maudsley score Safety Outcomes -Adverse events -Laboratory tests