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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000028040 |
Receipt No. | R000032104 |
Scientific Title | Examination of the association between patients' characteristic and endoscopic evaluation, especially gastroesophageal reflex disease. |
Date of disclosure of the study information | 2017/07/03 |
Last modified on | 2020/05/01 |
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 |
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Condition | ||
Condition | gastrointestinal disease | |
Classification by specialty |
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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 | |
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Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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Target sample size | 400 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
mattaku0810@gmail.com |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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).
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Results date posted |
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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. |
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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 | ||||||
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032104 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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