UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018752 |
|---|---|
| Receipt number | R000021694 |
| Scientific Title | Randomized, placebo-controlled, double-blind, parallel group comparative, phase 3 study of granulocyte-colony stimulating factor in patients with acute spinal cord injury |
| Date of disclosure of the study information | 2015/08/21 |
| Last modified on | 2019/06/19 07:32:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized, placebo-controlled, double-blind, parallel group comparative, phase 3 study of granulocyte-colony stimulating factor in patients with acute spinal cord injury
Acronym
G-CSF mediated spinal cord injury recovery induction trial(G-SPIRIT)
Scientific Title
Randomized, placebo-controlled, double-blind, parallel group comparative, phase 3 study of granulocyte-colony stimulating factor in patients with acute spinal cord injury
Scientific Title:Acronym
G-CSF mediated spinal cord injury recovery induction trial(G-SPIRIT)
Region
| Japan |
Condition
Condition
Acute spinal cord injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present trial is to elucidate therapeutic efficacy of G-CSF for motor paralysis of acute spinal cord injury
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Transition of motor paralysis(3 months after study drug administration)
Key secondary outcomes
(Efficacy)
Change in motor paralysis
Change in sensory paralysisThe degree of dysfunction associated with paralysis
The proportion of responder to the treatment
The level of neurological injury
SCIM, EQ-5D
(Safety)
Frequency of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
filgrastim 400ug/m2/day * 5day
Interventions/Control_2
placebo 400ug/m2/day * 5day
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) AIS Grade is B or C at screening
(2) AIS Grade is B or C at re-assessment of neurological status 48 hours (plus-minus 4 hours) after the injury
(3) Neurological level of injury is between C4 and C7
(4) Age betweem 16-85
(5) Patients who give informed consent to participate in the present trial
(6) Patients who can visit 1 month, 3 months, 6 months, and 12 months after administration
Key exclusion criteria
(1) Allergy to filgrastim.
(2) Hematologic malignancy or its previous history
(3) Malignant disease under treatment
(4) invasive treatment for myocardial infarction or angina pectoris within 6 months
(5) previous history of rombosis
(6) splenomegaly.
(7) consciousness disorder.
(8) Patients who are pregnant women, are willing to become pregnant in study period or are lactation.
(9) Neurological disorder which can affect neurological evaluation in the present trial
(10) Patients who receive filgrastim or methylprednisolone sodium succinate after the injury
(11) Patients who are expected to have rapid worsening of symptoms during the trial period
(12) Patients with serious complications
(13) Patients who can not start the rehabilitation in early by complications
(14) Patients with advanced dementia or mental illness
(15) Patients who have unstable physical status by multiple trauma or organ damage
(16) Patients who have fracture of extremities, the spine, or the other parts which can affect neurological evaluation in the present trial
(17) Patients who are participating in other trials, or received other study drugs within 12 weeks
(18) In addition, the patient whom investigator judged to be unsuitable as a patient.
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Ohtori |
Organization
Chiba University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
2608677
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-226-2117
G-SPIRIT@ml.chiba-u.jp
Public contact
Name of contact person
| 1st name | Tadami |
| Middle name | |
| Last name | Fujiwara |
Organization
Chiba University Hospital
Division name
Chiba Clinical Research Center
Zip code
2608677
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-222-7171
Homepage URL
t-fujiwara@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Medical Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital IRB
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
Tel
043-222-7171
G-SPIRIT@ml.chiba-u.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
JMA-IIA00217
Org. issuing International ID_1
Japan Medical Association
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 21 | Day |
Last modified on
| 2019 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021694
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
