Unique ID issued by UMIN | UMIN000007239 |
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Receipt number | R000008532 |
Scientific Title | A Phase III Study of SI-6603 in Patients with Lumbar Disc Herniation |
Date of disclosure of the study information | 2012/02/08 |
Last modified on | 2014/09/18 11:27:39 |
A Phase III Study of SI-6603 in Patients with Lumbar Disc Herniation
A Phase III Study of SI-6603 in Patients with Lumbar Disc Herniation
A Phase III Study of SI-6603 in Patients with Lumbar Disc Herniation
A Phase III Study of SI-6603 in Patients with Lumbar Disc Herniation
Japan |
Lumbar Disc Herniation
Orthopedics |
Others
NO
The objective of this study is to verify the superiority of SI-6603 versus a placebo in subjects with lumbar disc herniation.
Safety,Efficacy
Change from baseline of pain due to lumbar disc herniation
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
2
Treatment
Medicine |
SI-6603
Placebo
20 | years-old | <= |
70 | years-old | >= |
Male and Female
1.Patients diagnosed with lumbar disc herniation
2.Patients whose lumbar disc herniation failed to improve even after pharmacotherapy
1.Patients who have undergone lumbar operation in the past
2.Patients with diseases that can affect the results of this study
160
1st name | |
Middle name | |
Last name | Yukihiro Matsuyama, Kazuhiro Chiba |
Hamamatsu University School of Medicine, Kitasato Institute Hospital
Department of Orthopedic Surgery, Department of Orthopedic Surgery
20-1 Handayama 1-chome Higashiku Hamamatsushi Shizuoka, 9-1 Shirokane 5-chome Minatoku Tokyo
053-435-2297
spine-yu@hama-med.ac.jp
1st name | |
Middle name | |
Last name | Taiichi Shirogane |
SEIKAGAKU CORPORATION
Research & Development Div. Clinical Development Dept.
6-1, Marunouchi 1-chome Chiyoda-ku Tokyo, Japan
03-5220-8593
taiichi.shirogane@seikagaku.co.jp
SEIKAGAKU CORPORATION
SEIKAGAKU CORPORATION
Profit organization
NO
2012 | Year | 02 | Month | 08 | Day |
Unpublished
Completed
2011 | Year | 10 | Month | 25 | Day |
2012 | Year | 01 | Month | 01 | Day |
2012 | Year | 02 | Month | 07 | Day |
2014 | Year | 09 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008532
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