UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017647 |
|---|---|
| Receipt number | 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 10:51:05 |
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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
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
matsuoka_h@med.kindai.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020434
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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