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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017647
Receipt No. R000020434
Scientific Title Efficacy of duloxetine for cancer patients with neuropathic pain: Doubleblind, Randomized, Placebo controlled, exploratory trial
Date of disclosure of the study information 2015/05/21
Last modified on 2018/05/23

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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
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 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
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 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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