UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027953 |
|---|---|
| Receipt number | R000032014 |
| Scientific Title | Efficacy Comparison between Suvorexant and Zolpidem in Insomnia Patients Caused by Steroidal Drugs: A Randomised Control Trial. |
| Date of disclosure of the study information | 2017/06/28 |
| Last modified on | 2021/06/30 09:28:23 |
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Basic information
Public title
Efficacy Comparison between Suvorexant and Zolpidem in Insomnia Patients Caused by Steroidal Drugs: A Randomised Control Trial.
Acronym
Efficacy Comparison between Suvorexant and Zolpidem in Insomnia Patients Caused by Steroidal Drugs: A Randomised Control Trial.
Scientific Title
Efficacy Comparison between Suvorexant and Zolpidem in Insomnia Patients Caused by Steroidal Drugs: A Randomised Control Trial.
Scientific Title:Acronym
Efficacy Comparison between Suvorexant and Zolpidem in Insomnia Patients Caused by Steroidal Drugs: A Randomised Control Trial.
Region
| Japan |
Condition
Condition
Insomnia caused by steroidal drugs
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Clinical immunology |
| Psychosomatic Internal Medicine | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of Suvorexant compared with Zolpidem in patients of insomnia caused by steroidal drugs. We also investigate the effects on vital signs, glucose tolerance, serum lipid levels by improving insomnia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep maintenance effect and fall asleep effect in 1 week and 1 month from baseline.
Sleep maintenance effect
sTST subjective total sleep time
sWASO subjective wake after sleep onset
sNAW subjective number of asakening
Fall asleep effect
sTSO subjective time to sleep onset
Overall evaluation
ISI Insomnia Severity Index
PGI patient global impression of change
Adverse event
Key secondary outcomes
The effects on vital signs, glucose tolerance, serum lipid levels, blood pressure by improving insomnia.
vital sign
height
body weight
blood pressure
heart rate
Glucose tolerance
HbA1c
GA glycoalbumin
1.5-AG
Fasting blood glucose level
Fasting blood insulin level
Fasting blood C peptide
Accumulation of urine C peptide
Daily blood glucose fluctuation
Lipid
Total cholesterol
HDL cholesterol
LDL cholesterol
Triglyceride
Other
eGFR
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The group of Suvorexant:
65 years old and over is 15mg
under 65years old is 20mg
Drug administration for 28 days from baseline.
Evaluation on baseline, and day7, 28 from baseline.
Interventions/Control_2
The group of Zolpidem:
all age 5mg
Drug administration for 28 days from baseline.
Evaluation on baseline, and day7, 28 from baseline.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients suffered from insomnia caused by steroidal drugs with agree with the purpose of this study. They should apply to diagnosis criteria of DSM-5 insomnia A(as follow)...
A The patients remarkably has sleep disturbance about quantity and quality of sleep, and have one of these following symptoms...
(1)Difficulty falling asleep
(2)Difficulty maintaining sleep characterizes by frequent awakening, or difficulty falling asleep again after awkening
(3)Early morning awakening, and unable to fall asleep again
Key exclusion criteria
Exclude patients who fall under...
(1)Pregnant patient
(2)Patients who originally had insomnia
(3)Patients who are originally administered Suvolexant and the other sleep inducing agents
(4)Patients who have been administered Suvorexant and the other sleep inducing agents
(5)Patients who are administered anxiolytic
(6)Patients who have depression
(7)Patients who have sleep apnea syndrome
(8)Patients who have liver or kidney disorder
(9)Patients who have administered following drug that inhibits CYP3A4 strongly (itraconazole, clarithromycin, ritonavir, saquinavir, nelfinavir, indinavir, telaprevir, voriconazole)
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Okada |
Organization
Gifu Prefectural General Medical Center
Division name
General Internal Medicine
Zip code
Address
Kitaisiki 4-6-1, Gifu-city, Gifu, Japan
TEL
058-246-1111
hideyuki_okada_0920@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Okada |
Organization
Gifu Prefectural General Medical Center
Division name
General Internal Medicine
Zip code
Address
Kitaisiki 4-6-1, Gifu-city, Gifu, Japan
TEL
058-246-1111
Homepage URL
hideyuki_okada_0920@yahoo.co.jp
Sponsor or person
Institute
Gifu Prefectural General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gifu University Graduate School of Medicine, Department of General Internal Medicine
Gifu Municipal Hospital, Department of General Internal Medicine
Japanise Red Cross Gifu Hospital, Department of General Internal Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
岐阜県総合医療センター（岐阜県）
岐阜大学医学部附属病院（岐阜県）
岐阜市民病院（岐阜県）
岐阜赤十字病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 28 | 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
| 2017 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 27 | Day |
Last modified on
| 2021 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032014
