UMIN-CTR Clinical Trial

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
Email	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
Email	hideyuki_okada_0920@yahoo.co.jp

Sponsor
Institute	Gifu Prefectural General Medical Center
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032014