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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028475
Receipt No. R000032598
Scientific Title The efficacy of duloxetine for neuropathic pain a comparison of pregabalin
Date of disclosure of the study information 2017/08/01
Last modified on 2018/08/02

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Basic information
Public title The efficacy of duloxetine for neuropathic pain a comparison of pregabalin
Acronym The efficacy of duloxetine for neuropathic pain a comparison of pregabalin
Scientific Title The efficacy of duloxetine for neuropathic pain a comparison of pregabalin
Scientific Title:Acronym The efficacy of duloxetine for neuropathic pain a comparison of pregabalin
Region
Japan

Condition
Condition neuropathic pain
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish the efficacy of duloxetine for neurptahic pain
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Visual analogue scale (VAS) is assessed before, and, 1 week, 2 weeks, 1 month, 2 months, 3 months after drug administration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 duloxetine administration
Interventions/Control_2 pregabalin administration
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria neuropathic pain caused by failed back surgery syndrome or lumbar canal stenosis
Key exclusion criteria can not be self-assessment of pain
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiromi Fujii
Organization Kajiki Hospital
Division name Anesthesiology
Zip code
Address 1231-1 Nishihanajiri Kita-ku, Okayama
TEL 086-293-3355
Email hiromif@ktd.biglobe.ne.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Hiromi Fujiii
Organization Kajiki Hospital
Division name Anesthesiology
Zip code
Address 1231-1 Nishihanajiri Kita-ku, Okayama
TEL 086-293-3355
Homepage URL https://kajikihp.or.jp
Email hiromif@ktd.biglobe.ne.jp

Sponsor
Institute Kajiki Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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 梶木病院(岡山県) Kajiki Hospital (Okayama prefecture)

Other administrative information
Date of disclosure of the study information
2017 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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 06 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 01 Day
Last modified on
2018 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032598

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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