UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective study on role of mirtazapine for the relief of symptoms of cancer patients, including neuropathic pain.
Title of the study (Brief title)	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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Takao Aoyama
Organization	Tokyo University of Science
Division name	Faculty of Pharmaceutical Sciences
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	Takao Aoyama
Organization	Tokyo University of Science
Division name	Faculty of Pharmaceutical Sciences
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Pain, numbness (STAS-J version symptoms)
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