UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Masao Koda
Organization	Chiba University Graduate School of Medicine
Division name	Department of Orthopedics
Address	1-8-1 Inohana, Chuo-ku
TEL	043-226-2961
Email	masaokod@gmail.com

Public contact
Name of contact person	Yukiko Matsumoto
Organization	Chiba University Graduate School of Medicine
Division name	Department of Orthopedics
Address	1-8-1 Inohana, Chuo-ku
TEL	043-226-2961
Homepage URL
Email	chibaseikei8f@yahoo.co.jp

Sponsor
Institute	Chiba University Hospiotal
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014615