UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008500 |
|---|---|
| Receipt number | 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 13:03:40 |
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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
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
Sponsor or person
Institute
Department of Gastroenterology, Osaka City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009991
