Efficacy and Safety of DLBS2411 in the Management of GERD

Exclusion Criteria

• •1. For females of childbearing potential: pregnancy and breast-feeding.
• •* Patients must accept pregnancy tests during the trial if menstrual cycle is missed
• •* Fertile patients must use a reliable and effective contraceptive
• •2. Subjects with Zollinger Ellison syndrome or peptic ulcer diseases.
• •3. History or current evidence of Barrett's esophagus, esophageal strictures, odynophagia, pyloric stenosis, esophageal motility disorders (such as achalasia, scleroderma), anatomic esophageal abnormality (such as large hiatal hernia), pill-induced esophagitis.
• •4. Helicobacter pylori positive as confirmed by urea breath test (UBT).
• •5. History of esophageal, gastric or intestinal surgery including vagotomy.
• •6. Presence of comorbid diseases, such as symptomatic coronary artery disease (CAD) or cardiovascular disease, pulmonary disease (including asthma), hemostasis disorder, pancreatitis, malabsorption, or inflammatory bowel disease, and any other chronic diseases (including chronic cough, laryngitis), any serious infection(s), or malignancy(ies).
• •7. Inadequate liver function defined as ALT or alkaline phosphatase \> 2.5 times upper limit of normal.
• •8. Inadequate renal function defined as estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min.
• •9. Taking any proton pump inhibitors (PPIs) or sucralfate within 14 days prior to screening.
• •10. Requiring regular and chronic use of non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids, aspirin, anticholinergics, cholinergics, spasmolytics, or opiates, misoprostol or prokinetics.
• •11. Hypersensitivity to proton pump inhibitors.
• •12. Subjects with chronic alcoholism (\>40 g alcohol/day) or drug abuse.
• •13. Active heavy smokers (i.e. consuming \>10 cigarettes per day).
• •14. Participation in any other clinical studies within 30 days prior to screening.