UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023199 |
|---|---|
| Receipt number | 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 16:27:12 |
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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
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
pikkun46@hotmail.com
Sponsor or person
Institute
Toda Central General Hospital
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026720
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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