Unique ID issued by UMIN | UMIN000010982 |
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Receipt number | R000012858 |
Scientific Title | A confirmatory study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis) |
Date of disclosure of the study information | 2013/06/21 |
Last modified on | 2016/02/05 16:20:44 |
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)
A confirmatory study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis)
Japan |
Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis)
Orthopedics |
Others
NO
SI-657 is injected once a week for 5 consecutive weeks, and the efficacy and safety will be evaluated in patients with enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis).
After the fifth injection, patients will be assigned to observational or continuous injection groups, and the safety and efficacy are also evaluated in each group.
Safety,Efficacy
Confirmatory
Phase III
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
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Medicine |
Placebo
SI-657
16 | years-old | <= |
75 | years-old | > |
Male and Female
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.
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.
540
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 113-8519, Japan.
1st name | |
Middle name | |
Last name |
SEIKAGAKU CORPORATION
Clinical Development Dept. Research & Development Div.
6-1, Marunouchi 1-chome, Chiyoda-ku, Tokyo 100-0005, Japan.
KAKEN PHARMACEUTICAL CO., LTD/SEIKAGAKU CORPORATION
KAKEN PHARMACEUTICAL CO., LTD/SEIKAGAKU CORPORATION
Profit organization
NO
2013 | Year | 06 | Month | 21 | Day |
Unpublished
Completed
2013 | Year | 04 | Month | 26 | Day |
2013 | Year | 05 | Month | 31 | Day |
2013 | Year | 06 | Month | 17 | Day |
2016 | Year | 02 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012858
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