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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008594
Receipt No. R000007619
Scientific Title Open label study of analgesic property of minocycline for nociceptive/inflammatory pain and neuropathic pain
Date of disclosure of the study information 2012/08/01
Last modified on 2014/02/01

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Basic information
Public title Open label study of analgesic property of minocycline for nociceptive/inflammatory pain and neuropathic pain
Acronym Analgesic property of minocycline
Scientific Title Open label study of analgesic property of minocycline for nociceptive/inflammatory pain and neuropathic pain
Scientific Title:Acronym Analgesic property of minocycline
Region
Japan

Condition
Condition Nociceptive/Inflammatory pain and Neuropathic pain
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Chronic pain conditions, including nociceptive/inflammatory and neuropathic pain, are refractory to conventional medications. It is caused by activation of microglias in the spinal dorsal horn. Minocycline has a property to prevent the activation of microglias, and we confirm the analgesic property of minocycline in the present study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes an 11-point numeric rating scale of pain intensity
Key secondary outcomes Total scores of the McGill Pain Questionnaire (Japanese version) and Brief Pain Inventory (Japanese version)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 minocycline
Interventions/Control_2
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 patients with nociceptive and/or inflammatory pain
Key exclusion criteria patients with rheumatoid arthritis
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Sumitani
Organization The University of Tokyo Hospital
Division name Department of Anesthesiology and Pain Relief Center
Zip code
Address Hongo 7-3-1, Bunkyo, Tokyo
TEL 03-3815-5411
Email sumitanim-ane@h.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Sumitani
Organization The University of Tokyo Hospital
Division name Department of Anesthesiology and Pain Relief Center
Zip code
Address Hongo 7-3-1, Bunkyo, Tokyo
TEL 03-3815-5411
Homepage URL
Email sumitanim-ane@h.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization KAKENHI
Organization
Division
Category of Funding Organization
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
2012 Year 08 Month 01 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 No longer recruiting
Date of protocol fixation
2011 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
2012 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 08 Month 01 Day
Last modified on
2014 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007619

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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