UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017358 |
|---|---|
| Receipt number | R000020145 |
| Scientific Title | Anti-IL-6 therapy for chronic low back pain |
| Date of disclosure of the study information | 2015/04/30 |
| Last modified on | 2015/12/07 18:11:22 |
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Basic information
Public title
Anti-IL-6 therapy for chronic low back pain
Acronym
AIL6CLBP
Scientific Title
Anti-IL-6 therapy for chronic low back pain
Scientific Title:Acronym
AIL6CLBP
Region
| Japan |
Condition
Condition
chronic low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study of pain relief efficacy and safety of anti-IL6 inhibitor subcutaneous injection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Low back pain assessment and side effects of anti-IL6 therapy
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
anti-IL-6 inhibitor 162mg subcutaneous administration
Interventions/Control_2
Saline administered subcutaneously
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-exhibit low back pain, the leg pain.
-X-ray, CT, MRI, in the imaging findings such as discography, have the findings that can explain the symptoms.
-within between two vertebral disc degeneration.
-spinal instability. 5 degrees or more before and after bending X-ray.
-agreement to this test.
-resistance to conservative treatment.
Key exclusion criteria
-consciousness disorders
-Heart failure, renal failure, which exhibit liver failure, severe systemic complications such as respiratory failure
-cardiac function is severely degraded has a history of myocardial infarction
-Unstable angina merged patients cardiac function is severely degraded
-severe renal disease
(BUN 30 mg / dL or more or serum creatinine 2.0 mg / dL or more)
-severe liver disease
(AST (GOT) or ALT (GPT) is more than 100 U)
-respiratory function is severely degraded have-respiratory history
And infectious diseases, interstitial pneumonia, emphysema, malignant tumor
Other, if the study at the discretion of respiratory medicine physician it is determined difficult
-psychotic or psychiatric symptoms
-Potential women during pregnancy pregnant, lactating women
-Patients were judged to be inappropriate as-subject
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Ohtori |
Organization
Department of Orthopaedic surgery
Graduate school of medicine, Chiba University
Division name
Department of Orthopaedic surgery
Zip code
Address
1-8-1 Inohana Chuo-ku, Chiba, Japan 260-8670
TEL
043-226-2117
sohtori@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Sainoh |
Organization
Department of Orthopaedic surgery
Division name
Department of Orthopaedic surgery
Zip code
Address
1-8-1 Inohana Chuo-ku, Chiba, Japan 260-8670
TEL
043-226-2117
Homepage URL
sain3005@yahoo.co.jp
Sponsor or person
Institute
Department of Orthopaedic surgery
Graduate school of medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic surgery
Graduate school of medicine, Chiba University
Organization
Division
Category of Funding Organization
Other
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 | 04 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | 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
| 2015 | Year | 04 | Month | 30 | Day |
Last modified on
| 2015 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020145
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
