Efficacy of mosapride plus esomeprazole combination therapy in patients with gastroesophageal reflux disease
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0004062
- Lead Sponsor
- Pusan National University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of subjects whoes gastroesophageal reflux symptoms are subsided
- Secondary Outcome Measures
Name Time Method Percentage of subjects whoes gastroesophageal reflux symptoms are subsided;Evaluation of quality of life through GERD-Health Related Quality of Life