A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the healing rate and safety of Lafutidine in erosive esophagitis

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

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd
• Treatments: Famotidine; Lafutidine; Omeprazole

Criteria

Inclusion Criteria:

• Patients who had symptoms of heartburn with a diagnosis of grade A to D reflux esophagitis according to the Los Angeles classification

Exclusion Criteria:

• Gastric or duodenal ulcers (excluding ulcer scars)

• Concurrent presence of Barrett's esophagus

• A history of a poor response to H2RA or PPI given in the recommended dose for 8 weeks

• Other conditions considered by the attending physician to potentially affect the assessment of efficacy and safety