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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000005938
Receipt No. R000007017
Scientific Title The efficancy of pregabalin for peripheral neuropathic pain in spinal disease
Date of disclosure of the study information 2011/07/07
Last modified on 2011/07/06

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Basic information
Public title The efficancy of pregabalin for peripheral neuropathic pain in spinal disease
Acronym peripheral neuropathic pain in spinal disease
Scientific Title The efficancy of pregabalin for peripheral neuropathic pain in spinal disease
Scientific Title:Acronym peripheral neuropathic pain in spinal disease
Region
Japan

Condition
Condition spinal disease
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine efficancy of pregabalin for peripheral neuropathic pain in spinal disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual analog scale
Key secondary outcomes Self-Rating Depression Scale

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 pregabalin
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 1.Age 20-80yo
2.the patients with peripheral neuropathic pain in spinal disease
3.Normal renal function
4.concent with the trail
Key exclusion criteria 1.renal dysfunction,heart failure,liver dysfunction
2.A pregnant woman,woman in child bed,nursing mother
3.Determination as contratindication by doctors
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Tanaka
Organization Okayama University Hospital
Division name Dept.of Orthop.Surg.
Zip code
Address 2-5-1,Shikatacho,kita-ku,Okayama-city
TEL 0862357273
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Tetsunaga
Organization Okayama University Hospital
Division name Dept.of Orthop.Surg.
Zip code
Address 2-5-1,Shikatacho,kita-ku,Okayama-city
TEL 0862357273
Homepage URL
Email

Sponsor
Institute Okayama University Hospital,Dept.of Orthop.Surg.
Institute
Department

Funding Source
Organization none
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
2011 Year 07 Month 07 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 Preinitiation
Date of protocol fixation
2011 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 04 Month 01 Day
Date trial data considered complete
2012 Year 04 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 07 Month 06 Day
Last modified on
2011 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007017

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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