UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of duloxetine for cancer patients with neuropathic pain: Doubleblind, Randomized, Placebo controlled, exploratory trial
Acronym	Efficacy of duloxetine for cancer patients with neuropathic pain: Doubleblind, Randomized, Placebo controlled, exploratory trial
Scientific Title	Efficacy of duloxetine for cancer patients with neuropathic pain: Doubleblind, Randomized, Placebo controlled, exploratory trial
Scientific Title:Acronym	Efficacy of duloxetine for cancer patients with neuropathic pain: Doubleblind, Randomized, Placebo controlled, exploratory trial
Region	Japan

Condition
Condition	Cancer Pain
Classification by specialty	Hematology and clinical oncology Psychosomatic Internal Medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to assess the efficacy and safety of the addition of duloxetine for cancer patients with neuropathic pain that are non-responsive or intolerant to gabapentinoids.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain NRS (BPI-item4, 24-hour average intensity of global pain)on Day10
Key secondary outcomes	Hospital anxiety and depression scale, Short-Form Mcgill Pain Questionnaire 2, European Organization for Research and Treatment of Cancer Quority of Life Questionnaire Core 15 palliative, Pain Catastrophizing Scale, Adverse Events, Rescue dose, Pain NRS on Day10 by subgroups (nonresponsive or intolerant to gabapentinoids)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Duloxetine Group Treatment Period: 10 days (titration on day 3) Dose: Duloxetine 20-40mg/day every morning
Interventions/Control_2	Placebo Group Treatment Period: 10 days (titration on day 3) Dose: Placebo 1cap-2cap/day every morning
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	1) Cancer patients with neuropathic pain 2) Regularly scheduled systemic opioid therapy with insufficient analgesia 3) Non-responsive or intolerant to gabapentinoids 4) HADS<20 5) Age >= 20 6) Pain NRS(BPI item-4) >= 4 7) Creatinine clearance < 60 ml/min 8) AST<100 IU/L,ALT<100 IU/L,T-bil<2.0 mg/dl 9) Expected at least one month survival 10) Written informed consent
Key exclusion criteria	1) Chemotherapy-induced Peripheral Neuropathy 2) Progressive paralysis 3) Allergy to duloxetine 4) Depression 5) Patients who changed analgesic adjuvant agents within 2 days 6) Drug dependence or abuse 7) Uncontrolled psychiatric disease 8) Pregnancy or lactating patients 9) Patients who are judged as inadequate to participate to the trial due to other reasons by the doctor.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiromichi Matsuoka
Organization	Kinki University, Faculty of Medicine
Division name	Department of Psychosomatic Medicine
Zip code
Address	377-2, Ohno-higashi, Osakasayama City, Osaka, 589-8511
TEL	072-366-0221
Email	matsuoka_h@med.kindai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiromichi Matsuoka
Organization	Kinki University, Faculty of Medicine
Division name	Department of Psychosomatic Medicine
Zip code
Address	377-2, Ohno-higashi, Osakasayama City, Osaka, 589-8511
TEL	072-366-0221
Homepage URL
Email	matsuoka_h@med.kindai.ac.jp

Sponsor
Institute	Japan Agency for Medical Research and Development
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
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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	近畿中央胸部疾患センター（大阪府） 奈良県立医科大学附属病院（奈良県） 国立がん研究センター東病院（千葉県） 国立がん研究センター中央病院（東京都） 神戸大学医学部附属病院（兵庫県） 兵庫県立尼崎総合医療センター（兵庫県） 和泉市立病院（大阪府） 名古屋大学医学部附属病院（愛知県） 近畿大学医学部堺病院（大阪府） 近畿大学医学部附属病院（大阪府） 兵庫県立加古川医療センター（兵庫県） 関西医科大学（大阪府） 堺市立総合医療センター（大阪府）

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 21 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
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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	Completed
Date of protocol fixation	2015 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date	2015 Year 07 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 05 Month 21 Day
Last modified on	2018 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020434

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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