Safety to Evaluate the Efficacy and Safety of HIP1601 in Patients With Non Erosive Reflux Disease

A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase 3 Study to Compare Efficacy and Safety of HIP1601 in Patients With Non-Erosive Gastroesophageal Reflux Disease(NERD)

The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with Non-erosive gastroesphageal reflux disease.

A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase Ⅲ Study to Compare Efficacy and Safety of HIP1601 in Patients with Non-Erosive Gastroesophageal Reflux Disease(NERD)

Inclusion Criteria:

• 19≤ age ≤ 75
• Patients who were not observed mucosal break('not present') according to the LA classification(LA grade) on the EGDEsophago-Gastro-Duodenoscopy
• Patients who had experienced major symptom within 3 months Patients experienced heartburn or acid regurgitation within 7 days of screening day
• Patients who had experienced major symptom within 7 days before randomization. Entry into study also required that patients had experienced at least mild symptoms on at least 2 days/week or at least moderate symptoms on at least 1 day/week based on RDQ
• Patients understood the consents and purpose of this trial and signed consent form

Exclusion Criteria:

• Patients who have erosive GERD, Barrett's esophagus(other significant dysplasia of esophagus), gastroesophageal varicose veins, active peptic ulcer, gastrointestinal bleeding or malignant GI tumor confirmed by endoscopy
• Patients who have a history of gastric or gastroesophageal surgery
• Patients who have Zollinger-Ellison syndrome, eosinophilic esophagitis, primary esophageal motility disorder, acute upper gastrointestinal bleeding, Functional dyspepsia, IBS, IBD within 3 months before Visit 1
• Patients with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease.
• Patients Has a severe liver disorder(AST or ALT level exceeds 3 times more than normal upper range at Visit 1)
• Has a clinically significant renal failure(MDRD eGFR ≤ 59 mL/min/1.73m2 or Serum creatinine >2.0mg/dL at Visit 1)