![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | |||
Condition | Cancer Pain | ||
Classification by specialty |
|
||
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
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 |