Efficacy and Safety of HIP1601 Capsule

A Multicenter, Randomized, Double-blind, Phase Ⅲ Study to Compare Efficacy and Safety of HIP1601 40mg and HGP1705 40mg in Patients With Erosive Gastroesophageal Reflux Disease

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

Inclusion Criteria:

• 19≤ age ≤ 75
• Esophago-Gastro-Duodenoscopy LA classification ≥ grade A
• Patients experienced heartburn or acid regurgitation within 7 days of screening day
• Patients understood the consents and purpose of this trial and signed consent form

Exclusion Criteria:

• Has malignancy in the upper gastrointestinal tract, digestive ulcer, bleeding disorder or signs of gastrointestinal bleeding
• Has a severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range)
• Has a clinically significant renal failure(at screening day, MDRD eGFP ≤ 59 mL/min/1.73m2 or Serum creatinine >2.0mg/dL)
• Uncontrolled diabetes mellitus
• Before screening EGD, a patient who has taken H2-receptor antagonist or PPI within 2 weeks
• Before screening EGD, a patient who has taken drugs containing following list within 1 weeks : warfarin, anticholinergics for spasmolytic GI, antineoplastic agents, salicylates(except 100mg a day for prevention of cardiovascular disease), steroids, propulsives, sucralfate, NSAIDs, other antacids(e.g. antacids of prostaglandin analogs, antacids of aluminum/magnesium)