Efficacy Study of AGSPT201 Tablet to Treat Gastroesophageal Reflux Disease

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
• Treatments: Pantoprazole

Criteria

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.