UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014162
Receipt No. R000016490
Scientific Title Study of the efficacy and safety of ramelteon in insomnia of diabetes merger under the medical treatment of cancer patients
Date of disclosure of the study information 2014/06/04
Last modified on 2019/06/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.