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To evaluate the efficacy, safety, and cost-effectiveness of DWP14012 40 mg compared to esomeprazole magnesium enteric-coated tablets for the treatment of reflux esophagitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWP14012 | Experimental |
| |
| Lansoprazole | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP14012 | Drug | DWP14012 40mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| mucosal healing within 8 weeks | The percentage of subjects with endoscopically confirmed mucosal healing within 8 weeks. | 8weeks |
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Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for this study:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University Chen, M.D., Ph.D. | First Affiliated Hospital, Sun Yat-Sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minhu Chen | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38251791 | Derived | Zhuang Q, Liao A, He Q, Liu C, Zheng C, Li X, Liu Y, Wang B, Liu S, Zhang Y, Lin R, Chen H, Deng M, Tang Y, He C, Dai W, Tang H, Gong L, Li L, Xu B, Yang C, Zhou B, Su D, Guo Q, Li B, Zhou Y, Wang X, Fei S, Wu H, Wei S, Peng Z, Wang J, Li Y, Wang H, Deng T, Ding S, Li F, Chen M, Xiao Y. The efficacy and safety of fexuprazan in treating erosive esophagitis: a phase III, randomized, double-blind, multicenter study. J Gastroenterol Hepatol. 2024 Apr;39(4):658-666. doi: 10.1111/jgh.16471. Epub 2024 Jan 22. |
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| ID | Term |
|---|---|
| D004942 | Esophagitis, Peptic |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000634065 | fexuprazan |
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| D005759 |
| Gastroenteritis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |