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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CJ-12420 50mg QD | Experimental | CJ-12420 50mg tablet, once daily, oral administration for up to 8 weeks. |
|
| CJ-12420 100mg QD | Experimental | CJ-12420 100mg tablet, once daily, oral administration for up to 8 weeks. |
|
| Esomeprazole 40mg | Active Comparator | Esomeprazole 40mg, tablet. once daily, oral administration for up to 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJ-12420 100mg QD | Drug | 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. |
| 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 | 4-week or 8-week | |
| Symptom assessment by questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Poong Ryul Lee, Ph.D | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
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| ID | Term |
|---|---|
| C000631239 | tegoprazan |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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|
| Esomeprazole 40mg | Drug | 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 QD | Drug | 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. |
|
|
| 4-week or 8-week |
| 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 |