Unique ID issued by UMIN | UMIN000006712 |
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Receipt number | R000007933 |
Scientific Title | Randomized controlled trials of additional ramelteon to alpha1-blockers for nocturia with sleep disorders. |
Date of disclosure of the study information | 2011/11/12 |
Last modified on | 2011/11/11 23:52:51 |
Randomized controlled trials of additional ramelteon to alpha1-blockers for nocturia with sleep disorders.
Randomized controlled trials of additional ramelteon to alpha1-blockers for nocturia with sleep disorders.
Randomized controlled trials of additional ramelteon to alpha1-blockers for nocturia with sleep disorders.
Randomized controlled trials of additional ramelteon to alpha1-blockers for nocturia with sleep disorders.
Japan |
Benign prostatic hypertroplasia
Urology |
Others
NO
To examine the efficacy and tolerability of additional ramelteon to the alpha1-blockers for nocturi
Efficacy
Phase III
number of nocturia
IPSS, OABSS, N-QOL, PSQI, Safety
Interventional
Parallel
Randomized
Open -no one is blinded
No treatment
2
Treatment
Medicine |
Sleep instruction
Sleep instruction + Oral ramelteon 8mg
20 | years-old | <= |
Not applicable |
Male and Female
1) Nocturia of 2 times or more
2) 20 years old and more
3) Although alpha1 blocker is used, there is frequent nocturia.
4) Written informed consent
1) Patient with drug allergy
2) Severe liver dysfunction
3) During administration of Fluvoxamine maleate
4) Acute urinary tract infection
5) Physician deems inappropriate
100
1st name | |
Middle name | |
Last name | Hiroji Uemura |
Yokohama city university school of medicine
Department of urology
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
045-787-2800
1st name | |
Middle name | |
Last name | Takashi Kawahara |
Yokohama city university school of medicine
Department of urology
045-787-2800
Yokohama city university school of medicine department of urology
None
Self funding
Oguchi Higashi General Hospital
NO
2011 | Year | 11 | Month | 12 | Day |
Unpublished
Open public recruiting
2011 | Year | 09 | Month | 01 | Day |
2011 | Year | 11 | Month | 01 | Day |
2014 | Year | 05 | Month | 01 | Day |
2011 | Year | 11 | Month | 11 | Day |
2011 | Year | 11 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007933
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