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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017096
Receipt No. R000015115
Scientific Title Effectiveness of duloxetine for chemotherapy-induced peripheral neuropathy : a prospective study.
Date of disclosure of the study information 2015/04/10
Last modified on 2015/04/10

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Basic information
Public title Effectiveness of duloxetine for chemotherapy-induced peripheral neuropathy : a prospective study.
Acronym Effectiveness of duloxetine for CIPN : a prospective study.
Scientific Title Effectiveness of duloxetine for chemotherapy-induced peripheral neuropathy : a prospective study.
Scientific Title:Acronym Effectiveness of duloxetine for CIPN : a prospective study.
Region
Japan

Condition
Condition Patient with history of cancer
Classification by specialty
Not applicable
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study investigated the effect of duloxetine on CIPN caused by responsible chemotherapeutic agents as taxanes and oxaliplatin.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The response rate of duloxetine for CIPN.
Key secondary outcomes

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 Take a duloxetine
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with chemotherapy-induced peripheral neuropathy
Key exclusion criteria Patients with severe complitcations
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kae Okuma
Organization University of Tokyo Hospital
Division name Department of radiology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email ookumak-rad@h.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kae Okuma
Organization University of Tokyo Hospital
Division name Department of radiology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-5800-8667
Homepage URL http://u-tokyo-rad.jp/
Email ookumak-rad@h.y-tokyo.ac.jp

Sponsor
Institute University of Tokyo Hospital
Institute
Department

Funding Source
Organization University of Tokyo Hospital
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 10 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
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 03 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 10 Day
Last modified on
2015 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015115

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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