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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017358
Receipt No. 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

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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
Email 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
Email sain3005@yahoo.co.jp

Sponsor
Institute Department of Orthopaedic surgery
Graduate school of medicine, Chiba University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020145

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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