UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013480 |
|---|---|
| Receipt number | R000015739 |
| Scientific Title | Pathophyisiology of nocturnal gastro-esophageal reflux events and the effects of sleep medications and proton pump inhibitor on nocturnal gastro-esophageal reflux events |
| Date of disclosure of the study information | 2014/03/24 |
| Last modified on | 2019/05/27 23:03:27 |
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Basic information
Public title
Pathophyisiology of nocturnal gastro-esophageal reflux events and the effects of sleep medications and proton pump inhibitor on nocturnal gastro-esophageal reflux events
Acronym
The effects of sleep medications and PPI on nocturnal GER events
Scientific Title
Pathophyisiology of nocturnal gastro-esophageal reflux events and the effects of sleep medications and proton pump inhibitor on nocturnal gastro-esophageal reflux events
Scientific Title:Acronym
The effects of sleep medications and PPI on nocturnal GER events
Region
| Japan |
Condition
Condition
Gastro-esophageal reflux disease
Sleep disorders
Healthy subjects
Classification by specialty
| Medicine in general | Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the pathophysiology of nocturnal gastro-esophageal reflux (GER) events and the effects of both sleep medicines and proton pump inhibitor on nocturnal GER events
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of nocturnal gastro-esophageal reflux events
Key secondary outcomes
The number of transient lower esophageal sphincter relaxation events
The number of esophago-pahryngeal reflux events
The number of arousals
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
melatonin receptor agonist
Interventions/Control_2
nonbenzodiazepine
Interventions/Control_3
benzodiazepine
Interventions/Control_4
proton pump inhibitor
Interventions/Control_5
lactose
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. equall or older than 20-year-old
2. ability of writing concent
3. equall or more than 8 points in the FSSG questionnaire
4. presence of nocturnal reflux symptoms and presence of sleep disorders comfirmed by some questionnaires
5. having reflux esophagitis
Key exclusion criteria
1. past history of surgery on upper GI tract
2. past history of surgery on nasal cavities
3. taking medications which may affect motility of upper GI tract
4. having neuromuscular diseases
5. haing GI motility disorders
6. cannot stop taking sleep medications
7. having diseases in which interventions cannot be apllied
8. pregnant or nurcing status
9. subjects who are not appropriate for this study
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Shiko |
| Middle name | |
| Last name | Kuribayashi |
Organization
Gunma University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
371-8511
Address
3-39-15 Showa-machi Maebashi Gunma, 371-8511, Japan
TEL
027-220-8137
shikokuri@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiko |
| Middle name | |
| Last name | Kuribayashi |
Organization
Gunma University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
371-8511
Address
3-39-15 Showa-machi Maebashi Gunma, 371-8511, Japan
TEL
027-220-8137
Homepage URL
shikokuri@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
Non-profit Organization for Promotion of Gastrointestinal Disease Treatment Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Koyagi clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital
Address
3-39-15 Showa-machi, Maebashi, Gunma
Tel
027-220-8740
shikokuri@gunma-u.ac.jp
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
群馬大学医学部附属病院(群馬県)、こやぎ内科(群馬県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 21 | Day |
Last modified on
| 2019 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015739
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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