Unique ID issued by UMIN | UMIN000011938 |
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Receipt number | R000013939 |
Scientific Title | Granulocyte colony-stimulating factor-mediated neuroprotective therapy for acute aggravation of cervical compressive myelopathy: multicenter placebo controlled randomized single blinded trial. |
Date of disclosure of the study information | 2013/10/04 |
Last modified on | 2019/03/07 14:40:13 |
Granulocyte colony-stimulating factor-mediated neuroprotective therapy for acute aggravation of cervical compressive myelopathy: multicenter placebo controlled randomized single blinded trial.
Granulocyte colony-stimulating factor-mediated neuroprotective therapy for acute aggravation of cervical compressive myelopathy: multicenter placebo controlled randomized single blinded trial.
Granulocyte colony-stimulating factor-mediated neuroprotective therapy for acute aggravation of cervical compressive myelopathy: multicenter placebo controlled randomized single blinded trial.
Granulocyte colony-stimulating factor-mediated neuroprotective therapy for acute aggravation of cervical compressive myelopathy: multicenter placebo controlled randomized single blinded trial.
Japan |
cervical compressive myelopathy
Orthopedics |
Others
NO
To elucidate the efficacy of granulocyte colony-stimulating factor-mediated neuroprotective therapy for acute aggravation of cervical compressive myelopathy.
Efficacy
Exploratory
Explanatory
Phase II
Attenuation of functional impairment 2 weeks after the drug administration using Japanese Orthopedic Association Cervical Myelopathy Evaluation Score (JOA score).
Attenuation of motor paralysis (ASIA motor score), attenuation of sensory paralysis (ASIA sensory score), attenuation of quality of life (EQ-5D), spinal cord MRI
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Placebo
YES
YES
Institution is not considered as adjustment factor.
Central registration
2
Treatment
Medicine |
Granulocyte colony-stimulating factor
normal saline
20 | years-old | <= |
85 | years-old | >= |
Male and Female
Acute aggravation of cervical compressive myelopathy (who showed 2 pts. deterioration of JOA score within 1 month), patients with the voluntary consent documents upon participation, patients who can visit the hospital for one year
allergy for G-CSF, history of the malignancy of hematopoietic system, history of malignancy within 5 years, thoromboembolism, splenomegaly, disturbance of consciousness, pregnancy
60
1st name | |
Middle name | |
Last name | Takeo Furuya |
Chiba University Graduate School of Medicine
Department of Orthopedics
1-8-1 Inohana, Chuo-ku, Chiba
043-226-2961
takeo251274@yahoo.co.jp
1st name | |
Middle name | |
Last name | Yukiko Matsumoto |
Chiba University Graduate School of Medicine
Department of Orthopedics
1-8-1 Inohana, Chuo-ku, Chiba
043-226-2961
chibaseikei8f@yahoo.co.jp
Department of Orthopedic Surgery, Chiba University Graduate School of Medicine
none
Japanese Governmental office
NO
千葉大学医学部附属病院
2013 | Year | 10 | Month | 04 | Day |
Unpublished
Completed
2013 | Year | 10 | Month | 17 | Day |
2013 | Year | 12 | Month | 20 | Day |
2013 | Year | 10 | Month | 01 | Day |
2019 | Year | 03 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013939
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