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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000007257 |
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Date of registration:
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10/02/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Dose-finding Phase II Study of SI-657 in Patients with Enthesopathy (Plantar Fasciitis)
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Scientific title:
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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) |
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Date of first enrolment:
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2012/01/21 |
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Target sample size:
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180 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008563 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Phase II
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Countries of recruitment
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Japan
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Contacts
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Name:
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Toshiyuki Yorozuya/Hiroyuki Hosokawa |
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Address:
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28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo/6-1, Marunouchi 1-chome, Chiyoda-ku, Tokyo
Japan |
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Telephone:
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03-5977-5111(03-5220-8593) |
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Email:
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Affiliation:
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KAKEN PHARMACEUTICAL CO., LTD/SEIKAGAKU CORPORATION Clinical Development Department/Clinical Development Dept. Research & Development Div. |
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Name:
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Takeshi Muneta |
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Address:
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1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan.
Japan |
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Telephone:
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Email:
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Affiliation:
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Department of Orthopaedic Surgery, Tokyo Medical and Dental University. Division of Bio-Matrix, Graduate school. |
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Key inclusion & exclusion criteria
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Inclusion 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.
Age minimum:
20years-old
Age maximum:
75years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Enthesopathy (Plantar Fasciitis)
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Intervention(s)
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Placebo group
SI-657 high-dose group
SI-657 low-dose group
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Primary Outcome(s)
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Efficacy Outcome Change of Visual Analogue Scale (VAS) of pain at final evaluation.
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Secondary Outcome(s)
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Efficacy Outcomes -Roles and Maudsley score Safety Outcomes -Adverse events -Laboratory tests
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Source(s) of Monetary Support
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KAKEN PHARMACEUTICAL CO., LTD/SEIKAGAKU CORPORATION
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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