Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
- Registration Number
- NCT02028663
- Lead Sponsor
- HK inno.N Corporation
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 206
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CJ-12420 Bmg CJ-12420 50 volunteers will be administered CJ-12420 Bmg CJ-12420 Amg CJ-12420 50 volunteers will be administered CJ-12420 Amg CJ-12420 Cmg CJ-12420 50 volunteers will be administered CJ-12420 Cmg Esomeprazole 40mg Esomeprazole 50 volunteers will be administered Esomeprazole 40mg
- Primary Outcome Measures
Name Time Method Cumulative healing rate of erosive esophagitis at 8-week 8 week
- Secondary Outcome Measures
Name Time Method Healing rate of erosive esophagitis at 4-week 4 week
Trial Locations
- Locations (1)
Seoul National University Hospital and 11 others
🇰🇷Seoul, Korea, Republic of