UMIN-CTR Clinical Trial

Basic information
Public title	Study of the efficacy and safety of ramelteon in insomnia of diabetes merger under the medical treatment of cancer patients
Acronym	Study of the efficacy and safety of ramelteon in insomnia of diabetes merger under the medical treatment of cancer patients
Scientific Title	Study of the efficacy and safety of ramelteon in insomnia of diabetes merger under the medical treatment of cancer patients
Scientific Title:Acronym	Study of the efficacy and safety of ramelteon in insomnia of diabetes merger under the medical treatment of cancer patients
Region	Japan

Condition
Condition	Insomnia cancer patients under the medical treatment to be complicated by diabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism Hematology and clinical oncology Psychosomatic Internal Medicine Psychiatry
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Melatonin receptor agonist ramelteon has established safety and efficacy in insomnia patients in clinical trials, but none have examined it in diabetic patients and cancer patients. Consider effectiveness of ramelteon and safety in this study.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Sleep evaluation questionnaire
Key secondary outcomes

Base
Study type

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The group of oral administration before bedtime at 8 mg of ramelteon once once a day . Duration of treatment is 12 weeks.
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	insomnia patients
Key exclusion criteria	Patients with hypersensitivity to Rozerem. Patients with advanced liver dysfunction. Patient during administration of fluvoxamine maleate.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toru Kitazawa
Organization	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name	Division of Diabetes, Endocrinology and Metabolism
Zip code
Address	3-18-22 Bunkyo-ku, Tokyo Honkomagome
TEL	03-3823-2101
Email	cickkitazawa@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Toru Kitazawa
Organization	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name	Division of Diabetes, Endocrinology and Metabolism
Zip code
Address	3-18-22 Bunkyo-ku, Tokyo Honkomagome
TEL	03-3823-2101
Homepage URL
Email	cickkitazawa@gmail.com

Sponsor
Institute	Division of Diabetes, Endocrinology and Metabolism, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2014 Year 06 Month 04 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	Terminated
Date of protocol fixation	2014 Year 02 Month 10 Day
Date of IRB	2014 Year 02 Month 10 Day
Anticipated trial start date	2014 Year 02 Month 12 Day
Last follow-up date	2015 Year 02 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 06 Month 04 Day
Last modified on	2019 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016490