KCT0004062已完成未知
Randomized controlled trial comparing the efficacy of sustained release formula of mosapride plus esomeprazole combination therapy to esomeprazole monotherapy in patients with gastroesophageal reflux disease
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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