Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the optimal dose and administration methods of CJ-12420 in patients with erosive esophagitis by comparing the safety and efficacy of orally administered CJ-12420 to esomeprazole 40mg.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CJ HealthCare Corporation; HK inno.N Corporation
• Treatments: Esomeprazole

Criteria

Inclusion Criteria:

• Aged between 20-70

• Diagnosed with Erosive Esophagitis by Esophagogastroduodenoscopy (EGD) and classified into LA Grade A to D within 14 days before randomization to treatment

Exclusion Criteria:

• Patients who cannot undergo EGD

• Patients diagnosed with irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or suspected IBS

• Patients who took PPIs within 2 weeks prior to study drug administration

• Long-term use of nonsteroidal anti-inflammatory drugs throughout the study

• Clinically significant abnormal laboratory values during screening