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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023199
Receipt No. R000026720
Scientific Title The effects of suvorexant on sleep disorder and clinical findings of hemodialysis patients
Date of disclosure of the study information 2016/07/16
Last modified on 2016/07/16

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Basic information
Public title The effects of suvorexant on sleep disorder and clinical findings of hemodialysis patients
Acronym The effects of suvorexant on sleep disorder and clinical findings of hemodialysis patients
Scientific Title The effects of suvorexant on sleep disorder and clinical findings of hemodialysis patients
Scientific Title:Acronym The effects of suvorexant on sleep disorder and clinical findings of hemodialysis patients
Region
Japan

Condition
Condition Insomnia, maintenance hemodialysis patient
Classification by specialty
Nephrology Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. To evaluate the effect and safety of suvorexant for maintenance blood dialysis patients with sleep disorder
2. To evaluate the effect of suvorexant for clinical findings related to hemodialysis treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Athens insomnia scale
Key secondary outcomes 1. Adverse effects
2. Self administered questionnaire about insomnia
3. Clinical findings (BMI, pre dialysis blood pressure, interdialytic weight gain, change of blood pressure during dialysis) and blood examinations

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The patients receive Suvorexant 20mg per day for 3 months. If the patients are elderly, they receive Suvorexant 15mg per day for 3 months. If the patients are already receiving other sleeping pills, we add Suvorexant to them.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients who receiving maintenance blood dialysis patients
2.Patients with insomnia
3.Patients who gave their written informed consent to participate for the present study
4.Age is 20 years old or more and gender is male or female
Key exclusion criteria 1. Severe liver dysfunction
2. Severe respiratory dysfunction
3. Severe brain disorder
4. Patients having agents inhibiting CYP3A
5. Patients with severe dementia
6. Patients with no sleep wake rhythm due to bedridden state
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Ino
Organization Toda Central General Hospital
Division name Department of Nephrology
Zip code
Address 1-19-3 Hon-tyou, Toda city, Saitama
TEL 048-442-1111
Email pikkun46@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Jun Ino
Organization Toda Central General Hospital
Division name Department of Nephrology
Zip code
Address 1-19-3 Hon-tyou, Toda city, Saitama
TEL 048-442-1111
Homepage URL
Email pikkun46@hotmail.com

Sponsor
Institute Toda Central General Hospital
Institute
Department

Funding Source
Organization None
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 16 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
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 16 Day
Last modified on
2016 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026720

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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