Unique ID issued by UMIN | UMIN000014162 |
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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 |
Study of the efficacy and safety of ramelteon in insomnia of diabetes merger under the medical treatment of cancer patients
Study of the efficacy and safety of ramelteon in insomnia of diabetes merger under the medical treatment of cancer patients
Study of the efficacy and safety of ramelteon in insomnia of diabetes merger under the medical treatment of cancer patients
Study of the efficacy and safety of ramelteon in insomnia of diabetes merger under the medical treatment of cancer patients
Japan |
Insomnia cancer patients under the medical treatment to be complicated by diabetes
Medicine in general | Endocrinology and Metabolism | Hematology and clinical oncology |
Psychosomatic Internal Medicine | Psychiatry |
Malignancy
NO
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.
Efficacy
Confirmatory
Pragmatic
Not applicable
Sleep evaluation questionnaire
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
The group of oral administration before bedtime at 8 mg of ramelteon once once a day . Duration of treatment is 12 weeks.
Not applicable |
Not applicable |
Male and Female
insomnia patients
Patients with hypersensitivity to Rozerem. Patients with advanced liver dysfunction. Patient during administration of fluvoxamine maleate.
100
1st name | |
Middle name | |
Last name | Toru Kitazawa |
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division of Diabetes, Endocrinology and Metabolism
3-18-22 Bunkyo-ku, Tokyo Honkomagome
03-3823-2101
cickkitazawa@gmail.com
1st name | |
Middle name | |
Last name | Toru Kitazawa |
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division of Diabetes, Endocrinology and Metabolism
3-18-22 Bunkyo-ku, Tokyo Honkomagome
03-3823-2101
cickkitazawa@gmail.com
Division of Diabetes, Endocrinology and Metabolism, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
None
Self funding
NO
2014 | Year | 06 | Month | 04 | Day |
Unpublished
Terminated
2014 | Year | 02 | Month | 10 | Day |
2014 | Year | 02 | Month | 10 | Day |
2014 | Year | 02 | Month | 12 | Day |
2015 | Year | 02 | Month | 12 | Day |
2014 | Year | 06 | Month | 04 | Day |
2019 | Year | 06 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016490
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