Efficacy Study of AGSPT201 Tablet to Treat Gastroesophageal Reflux Disease

Double Blinded, Randomized, Active Drug Comparative, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of AGSPT201 in GERD Patients

The purpose of this study is to evaluate treatment in Gastroesophageal Reflux Disease (GERD) patients (aged 18~75) with endoscopically proven GERD treated with AGSPT201 Tablet.

This study is 4,8 weeks, outpatient, multicenter, randomized, double-blinded, active drug comparative, therapeutic confirmatory clinical study to evaluate the efficacy and safety of AGSPT201 in erosive esophagitis patients.

Inclusion Criteria:

• aged 18~75 years
• Patients whose esophageal lesions graded over LA A grade (The severity of lesions is classified by LA classification)
• Patients whose typical reflux symptoms such as heartburn, acid regurgitation, acid reflux and esophagus irritation during the past 3 month
• Symptoms on at least 2 days of the past 7 days

Exclusion Criteria:

• PPI treatment within 4 weeks before dosing or treatment of H2 blocker, sucralfate, prokinase NSAID (except low dose aspirin) within 2 weeks before dosing.
• Patients whose history of GI tract resection or vagotomy.
• Barrett's oesophagus greater than 3cm in length and high-grade dysplasia.
• Acid irrelevant Heartburn and regurgitation.
• Zollinger Ellison syndrome
• Hypersensitive and/or allergy to Pantoprazole and/or other PPI
• Pregnancy and lactation
• peptic ulcer
• serious hepatic
• any other renal, cardiac or haematological disease.
• Patients participated any other clinical studies during the past 3 months.