UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Completed
Unique ID issued by UMIN UMIN000007747
Receipt No. 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

* 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 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email

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
Email

Sponsor
Institute Higashi-Sumiyoshi Morimoto Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009125


Contact us.