Unique ID issued by UMIN | UMIN000007257 |
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Receipt number | R000008563 |
Scientific Title | A Dose-finding Phase II Study of SI-657 in Patients with Enthesopathy (Plantar Fasciitis) |
Date of disclosure of the study information | 2012/02/10 |
Last modified on | 2012/11/29 10:50:30 |
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)
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)
Japan |
Enthesopathy (Plantar Fasciitis)
Orthopedics |
Others
NO
The study objectives are to evaluate the efficacy and safety, and to determine the recommended dose of SI-657 in patients with enthesopathy (plantar fasciitis).
Safety,Efficacy
Exploratory
Phase II
Efficacy Outcome
Change of Visual Analogue Scale (VAS) of pain at final evaluation.
Efficacy Outcomes
-Roles and Maudsley score
Safety Outcomes
-Adverse events
-Laboratory tests
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
3
Treatment
Medicine |
Placebo group
SI-657 high-dose group
SI-657 low-dose group
20 | years-old | <= |
75 | years-old | > |
Male and Female
-Patients diagnosed with plantar fasciitis
-Patients with 12 weeks or longer symptoms
-Patients between 20 and 75 years old
-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.
180
1st name | |
Middle name | |
Last name | Takeshi Muneta |
Department of Orthopaedic Surgery, Tokyo Medical and Dental University.
Division of Bio-Matrix, Graduate school.
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan.
1st name | |
Middle name | |
Last name | Toshiyuki Yorozuya/Hiroyuki Hosokawa |
KAKEN PHARMACEUTICAL CO., LTD/SEIKAGAKU CORPORATION
Clinical Development Department/Clinical Development Dept. Research & Development Div.
28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo/6-1, Marunouchi 1-chome, Chiyoda-ku, Tokyo
03-5977-5111(03-5220-8593)
KAKEN PHARMACEUTICAL CO., LTD/SEIKAGAKU CORPORATION
KAKEN PHARMACEUTICAL CO., LTD/SEIKAGAKU CORPORATION
Profit organization
Japan
NO
2012 | Year | 02 | Month | 10 | Day |
Unpublished
Completed
2011 | Year | 12 | Month | 09 | Day |
2012 | Year | 01 | Month | 21 | Day |
2012 | Year | 02 | Month | 09 | Day |
2012 | Year | 11 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008563
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