UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058402 |
|---|---|
| Receipt number | R000066649 |
| Scientific Title | Use-result survey to evaluate the safety and outcome of QUVIVIQ use in patients with insomnia |
| Date of disclosure of the study information | 2025/07/08 |
| Last modified on | 2025/07/08 15:58:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Use-result survey to evaluate the safety and outcome of QUVIVIQ use in patients with insomnia
Acronym
Use-result survey to evaluate the safety and outcome of QUVIVIQ use in patients with insomnia
Scientific Title
Use-result survey to evaluate the safety and outcome of QUVIVIQ use in patients with insomnia
Scientific Title:Acronym
Use-result survey to evaluate the safety and outcome of QUVIVIQ use in patients with insomnia
Region
| Japan |
Condition
Condition
insomnia
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of QUVIVIQ Tablets 25 mg and QUVIVIQ Tablets 50 mg in patients with insomnia under actual conditions of use.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Phase IV
Assessment
Primary outcomes
Safety
Adverse events(AE)
Adverse Drug Reaction(ADR)
Key secondary outcomes
Efficacy
sLSO(Subjective Latency to Sleep Onset)
sTST(Subjective Total Sleep Time)
sWASO(Subjective wake after sleep onset)
Questions about sleeping and daytime symptoms as reported by the patients themselves
Overall improvement
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with insomnia treated with this drug
Key exclusion criteria
None
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | ryoko |
| Middle name | |
| Last name | suzuki |
Organization
Nxera Pharma Japan Co.,Ltd
Division name
Drug Safety,PMS
Zip code
107-0052
Address
9-7-2 Akasaka Minato-ku Tokyo 107-0053,Japan
TEL
03-5962-5718
ryoko.suzuki@nxera.life
Public contact
Name of contact person
| 1st name | ryoko |
| Middle name | |
| Last name | suzuki |
Organization
Nxera Pharma Japan Co.,Ltd
Division name
Drug Safety,PMS
Zip code
107-0052
Address
9-7-2 Akasaka Minato-ku Tokyo 107-0053,Japan
TEL
03-5962-5718
Homepage URL
ryoko.suzuki@nxera.life
Sponsor or person
Institute
Nxera Pharma Japan Co.,Ltd
Institute
Department
Personal name
Funding Source
Organization
Nxera Pharma Japan Co.,Ltd
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
None
Address
None
Tel
None
None
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
| 2025 | Year | 07 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 07 | Month | 08 | Day |
Last modified on
| 2025 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066649
