UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the association between patients' characteristic and endoscopic evaluation, especially gastroesophageal reflex disease.
Acronym	Examination of the association between patients' characteristic and endoscopic evaluation.
Scientific Title	Examination of the association between patients' characteristic and endoscopic evaluation, especially gastroesophageal reflex disease.
Scientific Title:Acronym	Examination of the association between patients' characteristic and endoscopic evaluation.
Region	Japan

Condition
Condition	gastrointestinal disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to determine the characteristics of patients without Helicobacter pylori (H. pylori) infection who were prescribed antacid medications (potassium-competitive acid blockers [P-CAB], proton pump inhibitors [PPI], and/or H2 receptor antagonist) and had no upper gastrointestinal lesions detected by endoscopy.
Basic objectives2	Others
Basic objectives -Others	factor
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Factors that increase or decrease the prescription of antacids.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	55 years-old <=
Age-upper limit	89 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients who underwent upper gastrointestinal endoscopy in our institution between August 2017 to July 2018.
Key exclusion criteria	All participants were H. pylori-negative according to serum antibody concentrations and/or the urea breath tests. Patients with a history of upper gastrointestinal tract surgery and those taking low-dose aspirin and/or NSAIDs were excluded.
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Takuya Middle name Last name Matsunaga
Organization	Saiseikai Karatsu Hospital
Division name	Divison of internal medicine
Zip code	847-0852
Address	Saiseikai Karatsu Hospital, Motohata 817 Karatsu, Saga 847-0852, Japan
TEL	0955-73-3175
Email	mattaku0810@gmail.com

Public contact
Name of contact person	1st name Takuya Middle name Last name Matsunaga
Organization	Saiseikai Karatsu Hospital
Division name	Division of Gastroenterology
Zip code	847-0852
Address	Saiseikai Karatsu Hospital, Motohata 817 Karatsu, Saga 847-0852, Japan
TEL	0955-73-3175
Homepage URL
Email	mattaku0810@gmail.com

Sponsor
Institute	Saiseikai Karatsu Hospital
Institute
Department

Funding Source
Organization	This work was supported in part by Grants-in-Aid for Scientific Research from Japan Society for the Promotion of Science (KAKEN) 17K09307 (KF) .
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saiseikai Karatsu Hospital
Address	Saiseikai Karatsu Hospital, Motohata 817 Karatsu, Saga 847-0852, Japan
Tel	0955-73-3175
Email	info@saiseikai-karatsu.com

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	2017 Year 07 Month 03 Day

Related information
URL releasing protocol	https://doi.org/10.1159/000506153
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.1159/000506153
Number of participants that the trial has enrolled	420
Results	Age was a risk factor for being prescribed antacids in both the middle-aged (P = 0.002) and older age group (P = 0.007). Other assessed lifestyle-related factors had no effect on rate of antacid prescription. Hiatal hernia was significantly associated with a higher rate of prescription of antacids in the middle-aged group (P = 0.002). Use of Ca-blockers was significantly associated with rate of prescription of antacids in the older age group (P = 0.013), but not in the middle-aged group (P = 0.099).
Results date posted	2019 Year 09 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	In both the middle-aged (55-69 years) and older age group (70-89 years), the average age was greater in the antacid than in the no antacid group (P = 0.005, P = 0.013, respectively). Sex and BMI had no effect on the rate of antacid prescription to patients who had no lesions detected by endoscopy in the upper gastrointestinal tract. Antacid medicines were significantly less frequently prescribed to habitual alcohol drinkers than to non-habitual alcohol drinkers in the older age group (P = 0.011), whereas there was a non-significant tendency for them to be less frequently prescribed to drinkers in the middle-aged group (P = 0.054). Smoking, eating styles, and exercise habits had no influence on prescription of antacid medicines, whereas in the older age group they were less frequently prescribed to patients who ate their evening meal within 2 h of bedtime three times a week (evening meal) than to those who ate their evening meal earlier (P = 0.049). Regarding comorbidities, the rate of prescription of antacid medicines was significantly higher in patients with hiatus herniation than in those without it in the middle-aged group (P < 0.001). The prescription rate was higher in patients with hypertension than in those without it in the middle-aged group (P = 0.023), particularly in those taking Ca-blockers (P = 0.045 in the middle-aged group; P = 0.027 in the older age group). Other comorbidities such as dyslipidemia, hyperuricemia, and diabetes mellitus had no influence on the rate of prescription of antacid medications.
Participant flow	Prior to upper gastrointestinal endoscopy, consent to participate in the study is obtained, and then a medical chart study is conducted.
Adverse events	nothing
Outcome measures	age, sex, BMI(body mass index), ate breakfast, ate their evening meal within 2 hours of bedtime, habitually drank carbonated drinks, habitually drank coffee, overate, ate a high fat diet, ate quickly, engaged in light exercise including walking activities for more than 1 hour every day, had worked out (heavy exercise) for more than 30 min twice a week for over 1 year, walked fast, was a habitual smoker, habitually drank alcohol, had hypertension, was taking Ca-blockers, had diabetes mellitus, had hypertriglyceridemia, had hyper-LDL cholesterolemia, had hypo-HDL cholesterolemia, had hyperuricemia, had esophageal hiatal hernia
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 02 Day
Date of IRB	2017 Year 06 Month 29 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2018 Year 07 Month 31 Day
Date of closure to data entry	2018 Year 07 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study type:Cross-sectional Study Object:Patients who will receive endoscopic examination in Saiseikai Karatsu Hospital from 1 August 2017 until 31 July 2018.

Management information
Registered date	2017 Year 07 Month 02 Day
Last modified on	2020 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032104

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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