Erosive Esophagitis, GERD
Conditions
Keywords
P-CAB, APA(Acid Pump Antagonist)
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.
Interventions
DRUGEsomeprazole
Once daily, Oral administration
DRUGCJ-12420
Once daily, Oral administration
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative healing rate of erosive esophagitis at 8-week | 8 week |
Secondary
| Measure | Time frame |
|---|---|
| Healing rate of erosive esophagitis at 4-week | 4 week |
Countries
South Korea
Outcome results
None listed