UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018816 |
|---|---|
| Receipt number | R000021765 |
| Scientific Title | Study on the relationship between arthritis and sleep disturbance |
| Date of disclosure of the study information | 2015/08/26 |
| Last modified on | 2018/02/27 18:13:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study on the relationship between arthritis and sleep disturbance
Acronym
Sleep study in arthritis
Scientific Title
Study on the relationship between arthritis and sleep disturbance
Scientific Title:Acronym
Sleep study in arthritis
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of arthritis on the sleep states of the patients with rheumatoid arthritis.To evaluate the effect of sleep states on the extent of arthritis in the patients with rheumatoid arthritis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Extent of the improvements in sleep states.
Key secondary outcomes
Extent of the improvements in arthritis scores.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with melatonin-mimetics, ramelteon.
Treatment with biological disease-modifying anti-rheumatic drugs.
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
Treatment with melatonin-mimetic, ramelteon: 1. Rheumatoid patients over 20 yrs old, fulfilling the ACR2010 classification criteria. 2.Rheumatoid patients confirmable to have sleep difficulties. 3.Rheumatoid patiets with full consents.
Treatment with biological DMARDs:1. Rheumatoid patients over 20 yrs old, fulfilling the ACR2010 classification criteria. 2.Rheumatoid patients with active diease requiring biologics. 3.Rheumatoid patiets with full consents.
Key exclusion criteria
1. Patients who experienced signifant or notable adverse events. 2. Patients who claimed to withdraw from the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunichi Shiozawa |
Organization
Kyushu University Beppu Hospital
Division name
Demartment of Medicine, Rheumatic Diseases Unit
Zip code
Address
4546 Tsurumihara, Beppu
TEL
0977-27-1656
shiozawa@beppu.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunichi Shiozawa |
Organization
Kyushu University Beppu Hospital
Division name
Department of Medicine, Rheumatic Disease Unit
Zip code
Address
4546 Tsurumihara, Beppu
TEL
0977-27-1656
Homepage URL
shiozawa@beppu.kyushu-u.ac.jp
Sponsor or person
Institute
Shunichi Shiozawa
Institute
Department
Personal name
Funding Source
Organization
Grant-in-aid for scientific study C
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Rheumatic Diseases Center, Kohnan Kakogawa Hospital
Name of secondary funder(s)
none
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
| 2015 | Year | 08 | Month | 26 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 27 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 27 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 26 | Day |
Last modified on
| 2018 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021765
