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This study is designed to confirm the non-inferiority of Tegoprazan 25mg, compared to Lansoprazole 15mg as maintenance therapy in patients with healed erosive esophagitis confirmed by endoscopy following oral administration once daily(QD) for 6 months.
This is a double blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25mg, lansoprazole 15mg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tegoprazan 25mg QD | Experimental | Tegoprazan 25mg tablet, once daily, oral administration |
|
| Lansoprazole 15mg QD | Active Comparator | Lansoprazole 15mg capsule, once daily, oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegoprazan 25mg QD | Drug | Tegoprazan 25mg tablets will be orally administered, once daily, for up to 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic remission rate of EE at 24-week | Endoscopic remission: No endoscopic recurrence of erosion(LA grade A to D) during maintenance period(24 weeks) | 24-week |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic remission rate of EE at 12-week | Endoscopic remission: No endoscopic recurrence of erosion(LA grades A to D) during maintenance period(12 weeks) | 12-week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oh Young Lee, Ph.D | Hanyang University Seoul Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University Seoul Hospital | Seoul | 133-792 | South Korea |
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| ID | Term |
|---|---|
| C000631239 | tegoprazan |
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Lansoprazole 15mg QD | Drug | Lansoprazole 15mg capsules will be orally administered, once daily, for up to 6 months. |
|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |