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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013480
Receipt No. 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

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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
Email 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
Email shikokuri@gunma-u.ac.jp

Sponsor
Institute Gunma University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015739

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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