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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name