UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013271
Receipt No. R000015353
Scientific Title An exploratory observational study to investigate patient background factors of Ramelteon responders
Date of disclosure of the study information 2014/03/01
Last modified on 2019/02/15

* 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 An exploratory observational study to investigate patient background factors of Ramelteon responders
Acronym PRam
Scientific Title An exploratory observational study to investigate patient background factors of Ramelteon responders
Scientific Title:Acronym PRam
Region
Japan

Condition
Condition Insomnia
Classification by specialty
Medicine in general Psychosomatic Internal Medicine Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objectives of this study are to evaluate the efficacy of Ramelteon in routine clinical practice using the Insomnia Severity Index (ISI) and investigate patient background factors of responders in an exploratory manner.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between the change in insomnia severity measured by the Insomnia Severity Index (ISI) and patient background factors
Key secondary outcomes ï½¥Relationship between the change in the Physical Component Summary (PCS-8) score or Mental Component Summary (MCS-8) score, which are QOL variables measured by the health-related QOL scale Short Form-8 (SF-8), and patient background factors
ï½¥Relationship between the change in insomnia severity measured by the Insomnia Severity Index (ISI) and the change in the QOL variable measured by the health-related QOL scale Short Form-8 (SF-8)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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.A patient with a diagnosis of insomnia with difficulty falling asleep who has been started on treatment with oral Ramelteon 8 mg/day
2.A patient who has answered the Insomnia Severity Index (ISI) questionnaire and the health-related QOL scale Short Form-8 (SF-8) in routine clinical settings before the start of Ramelteon therapy
3.A patient who has given consent to the use of clinical information for the study at 20 years of age or older
Key exclusion criteria 1.A patient who has received Ramelteon within 4 weeks before the start of oral ramelteon therapy
2.A patient with dementia
3.A patient with a history of hypersensitivity to Ramelteon
4.A patient with severe hepatic impairment
5.A patient with a history of drug abuse
6.A patient with psychiatric disease in an unstable condition
7.A patient who, in the opinion of the principal investigator or co-investigator, is not appropriate for the study
Target sample size 2200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Uchiyama
Organization Nihon University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 30-1 Oyaguchi Kamimachi, Itabashi-ku, Tokyo 173-8610, Japan
TEL 03-3972-8111
Email uchiyama.makoto@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeda Pharmaceutical Company Limited
Organization Takeda Pharmaceutical Company Limited
Division name Contact for Clinical Trial Information
Zip code
Address 12-10 Nihonbashi 2-chome Chuo-ku Tokyo Japan
TEL 03-3278-2111
Homepage URL
Email keisuke.nakatome@takeda.com

Sponsor
Institute Takeda Pharmaceutical Company Limited
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization Profit organization
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
2014 Year 03 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
2014 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 04 Day
Last follow-up date
2016 Year 05 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 10 Month 17 Day

Other
Other related information Observational study, Relationship between the change in insomnia severity measured by the Insomnia Severity Index (ISI) and patient background factors.

Management information
Registered date
2014 Year 02 Month 25 Day
Last modified on
2019 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015353

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.