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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008500
Receipt No. R000009991
Scientific Title Effect of ramelteon on sleep disturnace and reflux symptoms in patients with gastroesophagealreflux disease
Date of disclosure of the study information 2012/09/01
Last modified on 2015/02/23

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Basic information
Public title Effect of ramelteon on sleep disturnace and reflux symptoms in patients with gastroesophagealreflux disease
Acronym Ramelteon and GERD
Scientific Title Effect of ramelteon on sleep disturnace and reflux symptoms in patients with gastroesophagealreflux disease
Scientific Title:Acronym Ramelteon and GERD
Region
Japan

Condition
Condition GERD
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 There are strong evidences between gastroesophageal reflux disease. GERD and sleep disturbances. Several studies showed that prevalence of insomnia is high in GERD patients and treatment with GERD improves insomnia. However, effects of hypnotic drugs on GERD symptoms are unknown. We here examine effect of ramelteon on GERD symptoms and sleep disturbances by FSSG-scale and the Pittsburgh insomnia questionnaire index.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement in FSSG scores
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Ramelteon 8mg, 12 week administration
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. GERD patients with insomina (difficulty in falling asleep)
2. Outpatients
Key exclusion criteria 1. Allergy of ramelteon
2. Severe liver dysfunction
3. Allergy of fluvoxamine maleate
4. Other hyptonic drugs use
5. Nightworker, shift worker
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Fujiwara
Organization Osaka City University
Division name Gastroenterology
Zip code
Address 1-4-3 Asahimachi, Abenoku, Osaka 545-8585, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka City University
Division name Gastroenterology
Zip code
Address
TEL 06-6645-3811
Homepage URL
Email

Sponsor
Institute Department of Gastroenterology, Osaka City University
Institute
Department

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
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 09 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
2011 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 01 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
2012 Year 07 Month 23 Day
Last modified on
2015 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009991

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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