UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012486 |
|---|---|
| Receipt number | R000014615 |
| Scientific Title | Granulocyte colony-stimulating factor-mediated pain relieving therapy for spinal cord lesion-related neuropathic pain syndrome: a prospective, single-blinded, placebo controlled, dose-response trial |
| Date of disclosure of the study information | 2014/01/22 |
| Last modified on | 2019/03/07 14:41:46 |
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Basic information
Public title
Granulocyte colony-stimulating factor-mediated pain relieving therapy for spinal cord lesion-related neuropathic pain syndrome: a prospective, single-blinded, placebo controlled, dose-response trial
Acronym
G-CSF therapy for spinal cord lesion-related neuropathic pain
Scientific Title
Granulocyte colony-stimulating factor-mediated pain relieving therapy for spinal cord lesion-related neuropathic pain syndrome: a prospective, single-blinded, placebo controlled, dose-response trial
Scientific Title:Acronym
G-CSF therapy for spinal cord lesion-related neuropathic pain
Region
| Japan |
Condition
Condition
spinal cord lesion-related neuropathic pain syndrome
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present trial is to elucidate therapeutic effect and optimal dose of granulocyte colony-stimulating factor for spinal cord lesion-related neuropathic pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Pain reduction 1 month after drug administration (evaluated by numerical rating scale)
Key secondary outcomes
1. ratio of the patients showing 30% or 50% pain reduction 1 month after drug administration
2. Alteration of the score of Neuropathic pain symptoms inventory
3. Quantitative evaluation for neuropathic pain
4. QOL measure (EQ-5D)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Granulocyte colony-stimulating factor (5 micro g/kg/d dissolved in 100ml of normal saline for 5 days, div.)
Interventions/Control_2
Granulocyte colony-stimulating factor (10 micro g/kg/d dissolved in 100ml of normal saline for 5 days, div.)
Interventions/Control_3
normal saline 100ml for 5 days
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Spinal cord lesion-related neuropathic pain patients with at least 3 Months history.
2. Patients who did not respond conventional drug treatments.
3. Patients who are not scheduled for spinal surgery.
4. Definitive image or history of spinal cord lesions.
5. Patients who agree with the participation in the present trial with printed informed consent.
6. Patients who can participate the present trial for 6 Month.
Key exclusion criteria
1. Allergy for drugs to be tested.
2. History of hematologic malignancy.
3. Recent history (~5 years) of malignant disease.
4. Acute myocardial infarction or angina pectoris under treatment.
5. History or tendency of thorombosis or thoromboembolism.
6. Splenomegary.
7. Consciousness diorder.
8. Pregnancy.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Koda |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Orthopedics
Zip code
Address
1-8-1 Inohana, Chuo-ku
TEL
043-226-2961
masaokod@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiko Matsumoto |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Orthopedics
Zip code
Address
1-8-1 Inohana, Chuo-ku
TEL
043-226-2961
Homepage URL
chibaseikei8f@yahoo.co.jp
Sponsor or person
Institute
Chiba University Hospiotal
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 22 | 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
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 02 | Month | 19 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 04 | Day |
Last modified on
| 2019 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014615
