The purpose of this study is to confirm the efficacy of CJ-12420, Once daily (QD), compared to esomeprazole in patients with erosive esophagitis classified as Los Angeles (LA) classification grades A to D at Week 8.
This is a double blind, randomized, active controlled, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (CJ-12420 50mg, CJ-12420 100mg, esomeprazole 40mg). All subjects will be asked to take three tablets at the same time each day throughout the study, and also all subjects will be asked to record daytime and nighttime symptom in a subject diary on a daily basis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
302
CJ-12420 100mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of CJ-12420 100mg.
Esomeprazole 40mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of Esomeprazole 40mg.
CJ-12420 50mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of CJ-12420 50mg.
Samsung Medical Center
Seoul, South Korea
Cumulative healing rate of erosive esophagitis at 8-week
Time frame: 8 week
Healing rate of erosive esophagitis at 4-week
Time frame: 4-week
Symptom assessment by subject diary
Time frame: 4-week or 8-week
Symptom assessment by questionnaire
Time frame: 4-week or 8-week
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