UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000030826
Receipt No. 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 (Ver. 5)

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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
Email 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
Email ldgproject@merck.com

Sponsor
Institute MSD K.K.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035187