UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016648 |
|---|---|
| Receipt number | R000019322 |
| Scientific Title | Retrospective study on role of mirtazapine for the relief of symptoms of cancer patients, including neuropathic pain. |
| Date of disclosure of the study information | 2015/02/26 |
| Last modified on | 2016/04/29 15:44:31 |
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Basic information
Public title
Retrospective study on role of mirtazapine for the relief of symptoms of cancer patients, including neuropathic pain.
Acronym
Retrospective study on role of mirtazapine for the relief of symptoms of cancer patients, including neuropathic pain.
Scientific Title
Retrospective study on role of mirtazapine for the relief of symptoms of cancer patients, including neuropathic pain.
Scientific Title:Acronym
Retrospective study on role of mirtazapine for the relief of symptoms of cancer patients, including neuropathic pain.
Region
| Japan |
Condition
Condition
Malignancy
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively investigate role of mirtazapine and tricyclic antidepressants for the relief of symptoms including neuropathic pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain, numbness
(STAS-J version symptoms)
Key secondary outcomes
Insomnia, loss of appetite, anxiety, depression (STAS-J version symptoms)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cancer patients who have been prescribed any of mirtazapine (Reflex or Remeron) or amitriptyline (Tryptanol), nortriptyline (Noritren), amoxapine (Amoxan), imipramine (Tofranil), clomipramine (Anafranil) and cases complicated by neuropathic pain.
Key exclusion criteria
None.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Aoyama |
Organization
Tokyo University of Science
Division name
Faculty of Pharmaceutical Sciences
Zip code
Address
2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL
04-7121-3659
t-aoyama@rs.noda.tus.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Aoyama |
Organization
Tokyo University of Science
Division name
Faculty of Pharmaceutical Sciences
Zip code
Address
2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL
04-7121-3659
Homepage URL
t-aoyama@rs.noda.tus.ac.jp
Sponsor or person
Institute
Laboratory of pharmacotherapeutics, Tokyo University of Science
Institute
Department
Personal name
Funding Source
Organization
Laboratory of pharmacotherapeutics, Tokyo University of Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Hospital Organization Tokyo Medical Center
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 26 | 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
Pain, numbness
(STAS-J version symptoms)
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 | 02 | Month | 26 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Insomnia, loss of appetite, anxiety, depression (STAS-J version symptoms)
Management information
Registered date
| 2015 | Year | 02 | Month | 26 | Day |
Last modified on
| 2016 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019322
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
