UMIN-CTR Clinical Trial

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
Last 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
1st 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