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 |
* 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
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
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
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
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
