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| Name | Class |
|---|---|
| Hanyang University | OTHER |
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The primary objective of this study is to establish noninferiority of efficacy of DWP14012 (40 mg once daily) based on Timing of Administration.
Subjects will provide written informed consent for study participation and then undergo appropriate screening. Subjects who meet the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to either before meal group or after meal group. Subjects will be stratified into two groups according to Los Angeles classification grades (LA grades) A/B or C/D, as determined by upper gastrointestinal (GI) endoscopy. Subjects will visit the site at Week 2 for endoscopic assessment. Subjects whose mucosal breaks have completely healed will be prematurely withdrawn and considered to have reached end of treatment. Subjects whose mucosal breaks have not healed will continue to receive IPs for an additional 2 weeks and will visit the site for endoscopic assessment at Week 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fed state group | Experimental | just after a meal |
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| fasted state group | Experimental | before a meal |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP14012 | Drug | DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| healing rate at 4 week | Cumulative healing rate of erosive esophagitis at 4 week by endoscopy | 4 week |
| Measure | Description | Time Frame |
|---|---|---|
| healing rate at 2 week | Cumulative healing rate of erosive esophagitis at 2 week by endoscopy | 2 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HOJIN LEE | Contact | +82-2-550-8651 | hjlee200@daewoong.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University Medical Center | Seoul | 04763 | South Korea |
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| ID | Term |
|---|---|
| C000634065 | fexuprazan |
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| DWP14012 | Drug | DWP14012 40 mg, orally, once daily before a meal up to 4 weeks |
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