UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007747 |
|---|---|
| Receipt number | R000009125 |
| Scientific Title | The impact of Ramelteon on the risk of falling in orthopedic ward. -Single institutional non-randomized non-blinded comparative clinical trial- (RamFOW study) |
| Date of disclosure of the study information | 2012/05/01 |
| Last modified on | 2012/10/15 18:02:25 |
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Basic information
Public title
The impact of Ramelteon on the risk of falling in orthopedic ward. -Single institutional non-randomized non-blinded comparative clinical trial- (RamFOW study)
Acronym
The impact of Ramelteon on the risk of falling in orthopedic ward (RamFOW study)
Scientific Title
The impact of Ramelteon on the risk of falling in orthopedic ward. -Single institutional non-randomized non-blinded comparative clinical trial- (RamFOW study)
Scientific Title:Acronym
The impact of Ramelteon on the risk of falling in orthopedic ward (RamFOW study)
Region
| Japan |
Condition
Condition
in-hospital insomnia of the patients with orthopedic disorders
Classification by specialty
| Psychosomatic Internal Medicine | Orthopedics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of ramelteon in decreasing the incidence of falling or delirium of in-hospital orthopedic patients with insomnia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
frequency of falling and delirium of in-hospital orthopedic patients with insomnia
Key secondary outcomes
improving sleep disturbance evaluated by Athens Insomnia Scale, frequency of nurse cal during middle of the night
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
insomnia orthopedic patients with ramelteon during hospitalization
Interventions/Control_2
insomnia orthopedic patients with other soporific during hospitalization
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 of 20 years or older
2. insomnia orthopedic patients during hospitalization
Key exclusion criteria
1. Patients taking both ramelteon and other soporific
2. Patients with allergy for medications used in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Inui |
Organization
Higashi-Sumiyoshi Morimoto Hospital
Division name
Department of Rheumatology & Orthopaedics
Zip code
Address
3-2-66 Taka-ai, Higashi-Sumiyoshi Ku, Osaka 546-0014, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Higashi-Sumiyoshi Morimoto Hospital
Division name
Department of Rheumatology & Orthopaedics
Zip code
Address
3-2-66 Taka-ai, Higashi-Sumiyoshi Ku, Osaka 546-0014, Japan
TEL
06-6606-0010
Homepage URL
Sponsor or person
Institute
Higashi-Sumiyoshi Morimoto Hospital
Institute
Department
Personal name
Funding Source
Organization
Higashi-Sumiyoshi Morimoto Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 05 | Month | 01 | 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
| 2012 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 10 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2012 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 13 | Day |
Last modified on
| 2012 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009125
