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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016648
Receipt No. 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

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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
Email 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
Email t-aoyama@rs.noda.tus.ac.jp

Sponsor
Institute Laboratory of pharmacotherapeutics, Tokyo University of Science
Institute
Department

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
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

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
URL(English) https://upload.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
Registered date File name


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