UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015611
Receipt number R000018142
Scientific Title The clinical trials for pain relief and side effects of anti VEGF therapy for chronic lumbar discogenic low back pain -Part I ,II phase test -
Date of disclosure of the study information 2015/05/01
Last modified on 2015/05/01 18:17:59

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Basic information

Public title

The clinical trials for pain relief and side effects of anti VEGF therapy for chronic lumbar discogenic low back pain -Part I ,II phase test -

Acronym

Anti-VEGF therapy for discogenic low back pain

Scientific Title

The clinical trials for pain relief and side effects of anti VEGF therapy for chronic lumbar discogenic low back pain -Part I ,II phase test -

Scientific Title:Acronym

Anti-VEGF therapy for discogenic low back pain

Region

Japan


Condition

Condition

Discogenic low back pain

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

the purpose of this study is evaluation and investigation of the therapeutic and adverse effects of anti-VEGF therapy for low back pain

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Phase I,II


Assessment

Primary outcomes

low back pain visual analog scale(VAS)

Key secondary outcomes



Base

Study type


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

intradiscal administration of local anesthetic agent(bupivacaine)and pegaputanib Na group

Interventions/Control_2

intradiscal administration of local anesthetic agent (bupivacaine)group

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

15 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1.low back pain,leg pain
2.X-ray and MRI can explain the condition
3.less than 2 disc degeneration
4.Spinal instability
5.agreement with this study
6.refractory to 3 months of conservative treatments

Key exclusion criteria

1.loss of consiousness
2.case with history of spinal surgery, infection
3.severe systemic complications
4.diabetes mellitus
5.psychiatric disease
6.pregnant women and women suspected of being pregnant
7.case with malignancy
8.the case considered to be unsuitable as a subject

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ohtori Seiji

Organization

Graduate School of Medicine, Chiba University

Division name

Department of Orthopaedic Surgery

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba

TEL

043-226-2117

Email

sohotri@faculty.chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sato Jun

Organization

Graduate School of Medicine, Chiba University

Division name

Department of Orthopaedic Surgery

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba

TEL

043-226-2117

Homepage URL


Email

scottie6242000@yahoo.co.jp


Sponsor or person

Institute

Department of Orthopaedic Surgery,Graduate School of Medicine,Chiba University

Institute

Department

Personal name



Funding Source

Organization

AO spine

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2015 Year 05 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

2013 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 08 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 11 Month 05 Day

Last modified on

2015 Year 05 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018142


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name