UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028040 |
|---|---|
| Receipt number | 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 11:57:37 |
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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
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
mattaku0810@gmail.com
Sponsor or person
Institute
Saiseikai Karatsu Hospital
Institute
Department
Personal name
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032104
