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The purpose of study is to confirm the efficacy of DWP14012 Xmg, Once daily, compared to esomeprazole 40mg in patients with erosive gastroesophageal reflux disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWP14012 40mg | Experimental | Orally, once daily |
|
| Esomeprazole 40mg | Active Comparator | Orally, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP14012 40mg | Drug | DWP14012 40mg, tablet, orally, once daily for up to 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative healing rate of erosive esophagitis at 8week by endoscopy | at 8week |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative healing rate of erosive esophagitis at 4week by endoscopy | at 4week | |
| Reflux disease symptom assessment using RDQ(Reflux disease questionnaire) | Mean change of the frequency or severity of main symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University Medical Center | Seoul | South Korea |
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| DWP14012 40mg placebo |
| Drug |
DWP14012 40mg placebo-matching tablet, orally, once daily for up to 8 weeks |
|
| Esomeprazole 40mg | Drug | Esomeprazole 40mg tablet, orally, once daily for up to 8 weeks |
|
|
| Esomeprazole 40mg placebo | Drug | Esomeprazole 40mg placebo-matching tablet, orally, once daily for up to 8 weeks |
|
|
| at 4week and 8week |
| Quality of Life assessment using GERD-HRQL(GERD-Health related quality life) | Mean change of the total score of GERD-HRQL | at 4week and 8week |
| ID | Term |
|---|---|
| C000634065 | fexuprazan |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| 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 |
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