UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044383 |
|---|---|
| Receipt number | R000050698 |
| Scientific Title | Efficacy and safety of lemborexant in insomnia patients with nocturia. |
| Date of disclosure of the study information | 2021/05/31 |
| Last modified on | 2023/12/05 09:27:57 |
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Basic information
Public title
Efficacy and safety of lemborexant in insomnia patients with nocturia.
Acronym
Efficacy and safety of lemborexant in insomnia patients with nocturia.
Scientific Title
Efficacy and safety of lemborexant in insomnia patients with nocturia.
Scientific Title:Acronym
Efficacy and safety of lemborexant in insomnia patients with nocturia.
Region
| Japan |
Condition
Condition
Insomnia with nocturia
Classification by specialty
| Psychiatry | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of lemborexant in insomnia patients with nocturia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of Athens Insomnia Scale after 4 weeks of lemborexant treatment
Key secondary outcomes
The change of nocturnal urinary frequency, N-QOL after 4 weeks of lemborexant treatment and presence or absence of side effects within 4 weeks after starting oral administration
Base
Study type
Interventional
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
Lemborexant 5 mg is orally administered for 4 weeks before sleep for insomnia patients who urinate twice or more during nighttime
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Insomnia patients who urinate twice or more during nighttime
Key exclusion criteria
Patients with polyuria and nocturnal polyuria.
Patients with a history of hypersensitivity to the ingredients of this drug
Patients with pyuria or bacteriuria
Patients taking other insomnia medications
Patients taking CYP3A inhibitors
Patients with narcolepsy or cataplexy
Patients with sleep apnea syndrome
Patients with severe liver dysfunction or severe renal dysfunction
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Togo |
Organization
Kyowakai Medical Corporation Kyoritsu Hospital
Division name
Department of urology
Zip code
666-0016
Address
16-5 Chuo-cho, Kawanishi, Hyogo
TEL
072-758-1131
ytogohg@gmail.com
Public contact
Name of contact person
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Togo |
Organization
Kyowakai Medical Corporation Kyoritsu Hospital
Division name
Department of urology
Zip code
666-0016
Address
16-5 Chuo-cho, Kawanishi, Hyogo
TEL
072-758-1131
Homepage URL
ytogohg@gmail.com
Sponsor or person
Institute
Kyowakai Medical Corporation Kyoritsu Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyowakai Medical Corporation Kyoritsu Hospital
Address
16-5 Chuo-cho, Kawanishi, Hyogo
Tel
072-758-1131
ytogohg@gmail.com
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
| 2021 | Year | 05 | Month | 31 | 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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 31 | Day |
Last modified on
| 2023 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050698
