UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017264 |
|---|---|
| Receipt number | R000020037 |
| Scientific Title | Questionnaire survey for clinical effectiveness of generic product of hypnotic, zolpidem |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2025/05/01 10:09:22 |
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Basic information
Public title
Questionnaire survey for clinical effectiveness of generic product of hypnotic, zolpidem
Acronym
The survey of QOL associated with sleep due to zolpidem
Scientific Title
Questionnaire survey for clinical effectiveness of generic product of hypnotic, zolpidem
Scientific Title:Acronym
The survey of QOL associated with sleep due to zolpidem
Region
| Japan |
Condition
Condition
Insomnia
Classification by specialty
| Neurology | Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To make a comparative review of the clinical effectiveness of branded and generic products by making clear the quality of life relating to sleep of patient with zolpidem.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The scale of QOL relating to sleep
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of generic zolpidem.
The patients taking zolpidem tartrate tablet continuously or as needed, who were dosed at least seven days to two months ago.
Interventions/Control_2
Oral administration of branded zolpidem.
The patients taking zolpidem tartrate tablet continuously or as needed, who were dosed at least seven days to two months ago.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients taking zolpidem tartrate tablet continuously or as needed, who were dosed at least seven days to two months ago.
Key exclusion criteria
The patients with moderate to severe mental diseases such as schizophrenia and depression.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takayoshi |
| Middle name | |
| Last name | Maiguma |
Organization
Shujitsu University
Division name
Faculty of Pharmacy
Zip code
703-8516
Address
1-6-1 Nishigawara, Naka-ku, Okayama
TEL
086-271-8409
maiguma@shujitsu.ac.jp
Public contact
Name of contact person
| 1st name | Takayoshi |
| Middle name | |
| Last name | Maiguma |
Organization
Shujitsu University
Division name
Faculty of Pharmacy
Zip code
703-8516
Address
1-6-1 Nishigawara, Naka-ku, Okayama
TEL
086-271-8409
Homepage URL
maiguma@shujitsu.ac.jp
Sponsor or person
Institute
Shujitsu University
Institute
Department
Personal name
Funding Source
Organization
Shujitsu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shujitsu University Education and Research Ethics and Safety Committee
Address
1-6-1 Nishigawara, Naka-ku, Okayama 703-8516, Japan
Tel
086-271-8465
hayashi-2638@shujitsu.ac.jp
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
| 2015 | Year | 05 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2015 | Year | 04 | Month | 24 | Day |
Last modified on
| 2025 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020037
