UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014162
Receipt number 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 01:45:12

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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