Gastroesophageal reflux disease (GERD) is defined as a condition in which the contents of the stomach reflux into the esophagus leading to uncomfortable symptoms or complications. Typical symptoms include heartburn or reflux. Recent epidemiological studies indicate that the prevalence of GERD is rising rapidly in Asia, particularly in Korea and Japan. GERD can be divided into erosive reflux disease (ERD) and non-erosive reflux disease (NERD) according to the presence or absence of erosive changes in the esophagus during endoscopy. The problem in practice is that the quality of life is reduced in both ERD and NERD patients. Proton pump inhibitors (PPIs) have been shown to improve the quality of life of GERD patients safely and effectively, but several studies have reported that this effect of PPI is reduced in NERD patients compared to ERD patients. Mosapride is a gastrointestinal prokinetics that stimulates the 5-hydroxytipamine 4 (5-HT4) receptor and increases secretion of acetylcholine from the parasympathetic nerve endings to exacerbate gastric emptying and bowel movements. Some previous studies have reported that the combination of PPI and mosapride in patients with GERD is more effective in improving symptoms than in the use of PPI alone. However, PPI may be taken once a day before breakfast, but mosapride should be taken three times a day before breakfast, lunch, and dinner, so patients are not adhered to mosapride in clinical practice. To overcome this problem, a sustained-release formulation of several drugs has been introduced to increase the compliance of drug administration, and a sustained release formula of mosapride has been developed with mosapride once a day. The aim of this study was to compare the efficacy of PPI alone and PPI plus mosapride in the improvement of reflux symptoms in patients with GERD.

Treatment

If the test subject agrees to participate in the clinical trial, the screening number is given and the screening test results of the test subject are assessed. A randomization number is assigned only to the test subjects who meet the selection criteria and do not fall under the exclusion criteria, and receives block randomization at a 1:1 ratio among the two groups using the random number assigned to the computer.

Arm Label

Target Number of Participant

Arm Type

Arm Description

# How to take medication for clinical trial
1) ME group: 1 mg of mosapride and 20 mg of esomeprazole before breakfast
2) Test period: 8 weeks or 12 weeks (including 2 screening periods)
4) Method of administration: each 1  tablet should be taken orally once a day from the day after receiving the clinical test drug (the next day after randomization)

Arm Label

Target Number of Participant

Arm Type

Arm Description

# How to take medication for clinical trial
1) E group: esomeprazole 20 mg alone once before breakfast,
2) Test period: 8 weeks or 12 weeks (including 2 screening periods)
3) Method of administration: 1  tablet should be taken orally once a day from the day after receiving the clinical test drug (the next day after randomization)

Gender

Age

Description

1) Only adult men and women over 19 years old
2) Within the last 14 days, based on Visit 1, those with typical symptoms (heartburn or reflux) at least twice a week
3) Anyone who understands the information provided to him/her and who can understand and write the questionnaire
4) Those who have decided to voluntarily participate in this clinical trial and have agreed in writing

1) A person who shows signs of severe or malignant diseases including unintended weight loss, hematemesis, hematochezia, or jaundice
2) Within the last 3 months on Visit 1, upper gastrointestinal endoscopy shows pyloric stenosis, peptic ulcer (except for ulcer scar), Barrett's esophagus (3 cm or more), gastrointestinal varices, or gastrointestinal bleeding,
3) Those with primary esophageal motility disorders, pancreatitis, absorption disorders, inflammatory bowel diseases (Crohn's disease, ulcerative colitis, etc.), or irritable bowel syndrome
4) Patients with Zolinger-Ellison syndrome
5) Patients with eosinophilic esophagitis
6) Those who have been diagnosed with severe pulmonary disease within the last 3 months
7) Patients with severe liver dysfunction or liver disease (serum ALT, AST, GGT, total bilirubin more than twice the normal upper limit)
8) Patients with chronic renal disease or severe renal disease including renal dysfunction (serum BUN, creatinine more than twice the normal upper limit)
9) Uncontrolled diabetes, cerebrovascular disease
10) Patients who underwent surgery during the last 3 months
11) Those with a history of malignant tumors within 5 years
12) Persons with psychological illness, drug or alcohol abuse
13) Those who have hypersensitivity reactions  to medicines for clinical trials, drugs including esomeprazole, and other drugs (benzimidazoles, antibiotics, etc.)
14) Those who took PPI within 28 days of Visit 1
15) Those who took  Histamine H2 blocker, sucralfate, gastrointestinal exercise promoter, or antacid within 14 days of visit 1 
16) Pregnant women, lactating women or women who have not agreed to the appropriate use of contraception during the trial
(※ Proper contraceptive method: Condoms, oral contraceptives, injecting contraceptives for injection or use, intrauterine contraceptive devices, etc.)
17) Those who have received other clinical trial drugs within 3 months from the written consent
18) A person who is deemed not to be suitable for the clinical trial as determined by the tester

Percentage of subjects whoes gastroesophageal reflux symptoms are subsided

8 weeks later

Percentage of subjects whoes gastroesophageal reflux symptoms are subsided

4 weeks later

Evaluation of quality of life through GERD-Health Related Quality of Life

4 weeks and 8 weeks later

The addition of mosapride SR to esomeprazole in patients with GERD did not provide ad-ditional benefits in controlling GERD symptoms. However, considering the usefulness of conventional mosapride in patients with GERD, prospective, large-scale, multi-center studies are needed to elucidate the subpopulation of patients with GERD in whom addi-tional effects of mosapride SR are helpful for symptom control.