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
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
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
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
