UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015670 |
|---|---|
| Receipt number | R000018212 |
| Scientific Title | Efficacy of epidural administration of ant-TNF-alfa and anti-interleukin-6 receptor antibody onto spinal nerve for treatment of sciatica. |
| Date of disclosure of the study information | 2014/11/12 |
| Last modified on | 2014/11/12 11:06:17 |
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Basic information
Public title
Efficacy of epidural administration of ant-TNF-alfa and anti-interleukin-6 receptor antibody onto spinal nerve for treatment of sciatica.
Acronym
Anti-Cytokine therapy for radicular pain (ACTRP)
Scientific Title
Efficacy of epidural administration of ant-TNF-alfa and anti-interleukin-6 receptor antibody onto spinal nerve for treatment of sciatica.
Scientific Title:Acronym
Anti-Cytokine therapy for radicular pain (ACTRP)
Region
| Japan |
Condition
Condition
low back and radicular leg pain caused by spinal stenosis were investigated.
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the current study is to examine the effect of the anti-TNF-alfa and IL-6 receptor monoclonal antibodyon radicular pain by its epidural administration onto spinal nerves in patients with lumbar spinal stenosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain relief
side effect
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1% Xylocaine
Interventions/Control_2
1% Xylocaine + anti-TNF-alfa receptor antibody
Interventions/Control_3
1% Xylocaine + anti-interleukin-6 receptor antibody
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 Patients with low back pain, leg pain, or intermittent claudication
2 patients with pain that can beexplained X-ray, CT, MRIand discography.
Key exclusion criteria
1 Patients with impaired consciousness
2 Patients with severe heart failure, renal failure, liver failure and systemic complications such as respiratory failure.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Ohtori |
Organization
Graduate School of Medicine, Chiba University
Division name
Dept. of Orthopaedic Surgery
Zip code
Address
1-8-1 Inohana Chuo-ku, Chiba city, Chiba, Japan.
TEL
043-226-2117
sohotri@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Ohtori |
Organization
Graduate School of Medicine, Chiba University
Division name
Orthopaedic Surgery
Zip code
Address
1-8-1 Inohana Chuo-ku, Chiba city, Chiba, Japan.
TEL
043-226-2117
Homepage URL
sohotri@faculty.chiba-u.jp
Sponsor or person
Institute
Dept. of Orthopaedic Surgery, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Uehara Memorial Foundation Research Grant
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
| 2014 | Year | 11 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 08 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 12 | 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 | 12 | Day |
Last modified on
| 2014 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018212
