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The purpose of this study is to demonstrate 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 two treatment groups (CJ-12420 100 mg or esomeprazole 40 mg).
All subjects will be asked to take two 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CJ-12420 100 mg QD | Experimental | CJ-12420 100 mg, tablet, once daily, oral administration for up to 8 weeks |
|
| Esomeprazole 40 mg QD | Active Comparator | Esomeprazole 40 mg, tablet, once daily, oral administration for up to 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJ-12420 100 mg QD | Drug | CJ-12420 100 mg 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 100 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative healing rate of erosive esophagitis at 8-week | 8 week |
| Measure | Description | Time Frame |
|---|---|---|
| Healing rate of erosive esophagitis at 4-week | 4 week | |
| Symptom assessment by subject diary and questionnaire | 4 week or 8 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyun Chae Jung, Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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|
| Esomeprazole 40 mg QD | Drug | Esomeprazole 40 mg 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 40 mg. |
|
|
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |