UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030826 |
|---|---|
| Receipt number | R000035187 |
| Scientific Title | Cross-sectional survey on patients experience with suvorexant and other hypnotics in insomnia patients with nocturia |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2019/08/05 16:05:34 |
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Basic information
Public title
Cross-sectional survey on patients experience with suvorexant and other hypnotics in insomnia patients with nocturia
Acronym
Cross-sectional survey on patients experience with suvorexant and other hypnotics in insomnia patients with nocturia
Scientific Title
Cross-sectional survey on patients experience with suvorexant and other hypnotics in insomnia patients with nocturia
Scientific Title:Acronym
Cross-sectional survey on patients experience with suvorexant and other hypnotics in insomnia patients with nocturia
Region
| Japan |
Condition
Condition
Insomnia with nocturia
Classification by specialty
| Medicine in general | Psychiatry | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To characterize patient experiences with suvorexant or other sleep medications in insomnia patients with nocturia
Basic objectives2
Others
Basic objectives -Others
To characterize patient experiences (dosing, frequency of use, symptom relief and satisfaction) with suvorexant or other sleep medications in insomnia patients with nocturia, by a pharmacy-based survey
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Patient experiences with suvorexant including: dosing, frequency of use, symptom relief and satisfaction in insomnia patients with nocturia
Key secondary outcomes
Patient experiences with other sleep medications including: dosing, frequency of use, symptom relief and satisfaction in insomnia patients with nocturia
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age 40 years or older
Nocturia outpatients with experience of using suvorexant monotherapy or other sleep medication monotherapy during the most recent 30 day period prior to survey fielding
Stable treatment for nocturia (no change in medical treatment for nocturia, no history of invasive treatment for nocturia, within 3 months prior to survey fielding)
Key exclusion criteria
The following disease or symptom:
cognitive impairment
chronic pain
restless leg syndrome
sleep related breathing disorder
acute urinary tract infection
prostate cancer
urinary tract cancer
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Shoki |
| Middle name | |
| Last name | Okuda |
Organization
MSD K.K.
Division name
Medical Affairs
Zip code
102-8667
Address
1-13-12 Kudan-kita, Chiyoda-ku, Tokyo
TEL
03-6272-1067
ldgproject@merck.com
Public contact
Name of contact person
| 1st name | Shoki |
| Middle name | |
| Last name | Okuda |
Organization
MSD K.K.
Division name
Medical Affairs
Zip code
102-8667
Address
1-13-12 Kudan-kita, Chiyoda-ku, Tokyo
TEL
03-6272-1067
Homepage URL
ldgproject@merck.com
Sponsor or person
Institute
MSD K.K.
Institute
Department
Personal name
Funding Source
Organization
MSD K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NPO Clinical Research Enhancement Network Japan
Address
1-4-9, Itachibori, Nishi-ku, Osaka-shi, Osaka
Tel
06-4393-8403
osaka@sct-net.org
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
| 2018 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
Not disclosed
Publication of results
Published
Result
URL related to results and publications
Sano et al. (2018) J New Rem & Clin 67:1311-1326
Number of participants that the trial has enrolled
251
Results
Insomnia symptom that the patient felt most bothersome was nocturnal awakenings in both groups, and the frequency of insomnia symptoms was positively related to the number of nocturnal voids. In the suvorexant group, >=60% of patients answered "satisfied" with the treatment, and there was the relationship between the treatment satisfaction and voiding frequency. In the patients in the other hypnotics group, and there was no association between the treatment satisfaction and the number of nocturnal voids.
Results date posted
| 2019 | Year | 08 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Suvorexant group:
The ratio of man and woman was 27.0% and 73.0%, respectively, and 36.9% of the patients was 75 years old or over. 68.3% of the patients reported two voids per night.
Other hypnotics group:
The ratio of man and woman was 36.2% and 63.8%, respectively, and 63.8% of the patients was 75 years old or over. 69.2% of the patients reported two voids per night.
Participant flow
Two hundred and fifty-one patients were registered between January and February, 2018 at 160 pharmacies throughout Japan. Two patients whose medication could not be confirmed from the JMIRI databases were excluded from the analysis, and 249 patients (122 in the suvorexant group and 127 in the other hypnotics group) were included in the analysis population.
Adverse events
Not reported.
Outcome measures
Primary outcome:
- Patient experiences with suvorexant including: dosing, frequency of use, symptom relief and satisfaction in insomnia patients with nocturia
Secondary outcome:
- Patient experiences with other sleep medications including: dosing, frequency of use, symptom relief and satisfaction in insomnia patients with nocturia
The detail is described in the reprort (Sano et al. (2018) J New Rem & Clin 67:1311-1326).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a cross-sectional survey of insomnia patients with nocturia based on the dispensing pharmacy. The eligible subjects will be asked to complete a survey at pharmacies they visit to receive prescribed sleep medications. In this study, potential subjects will be screened by a pharmacist. A pilot survey will be done to confirm validity of the questionnaire and operational feasibility. Nocturia patients with experience of suvorexant monotherapy or other sleep medications will be asked to complete a survey. There will be no comparative analysis.
Management information
Registered date
| 2018 | Year | 01 | Month | 15 | Day |
Last modified on
| 2019 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035187
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