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The purpose of study is to confirm the efficacy of DWP14012 X mg QD, DWP14012 Y mg BID compared to placebo in patients with Acute or Chronic Gastritis
This study was designed as a multi-center, randomized, double-blind, placebo-controlled, parallel-group, phase 3 study to assess the efficacy and safety of oral administration of DWP14012 X mg QD, Y mg BID and placebo for 2 weeks in patients with acute and chronic gastritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWP14012 X mg QD | Experimental |
|
|
| DWP14012 Y mg BID | Experimental |
|
|
| placebo | Placebo Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP14012 X mg | Drug | DWP14012 X mg, tablet, orally, once daily for 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement rate of gastric mucosal erosion | Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erosion score) / Number of target cases) x 100 | at 2 weeks after the IP administration |
| Measure | Description | Time Frame |
|---|---|---|
| Cure rate of gastric mucosal erosion | Cure rate (%) = (Number of healed cases(0 erosions) / Number of target cases) x 100 | at 2 weeks after the IP administration |
| Cure rate of gastric mucosal edema |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36789577 | Derived | Kim GH, Choi MG, Kim JI, Lee ST, Chun HJ, Lee KL, Choi SC, Jang JY, Lee YC, Kim JG, Kim KB, Shim KN, Sohn CI, Kim SK, Kim SG, Jang JS, Kim N, Jung HY, Park H, Huh KC, Lee KJ, Hong SJ, Baek S, Han JJ, Lee OY. Efficacy and Safety of Fexuprazan in Patients with Acute or Chronic Gastritis. Gut Liver. 2023 Nov 15;17(6):884-893. doi: 10.5009/gnl220457. Epub 2023 Feb 15. |
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| DWP14012 X mg placebo |
| Drug |
DWP14012 X mg placebo-matching tablet, orally, once daily for 2 weeks |
|
| DWP14012 Y mg | Drug | DWP14012 Y mg, tablet, orally, twice daily for 2 weeks |
|
| DWP14012 Y mg placebo | Drug | DWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 weeks |
|
Cure rate (%) = (Number of healed cases(change of 2 to 1 in edema score) / Number of target cases) x 100
| at 2 weeks after the IP administration |
| Improvement rate of gastric mucosal erythema | Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erythema score) / Number of target cases) x 100 | at 2 weeks after the IP administration |
| Improvement rate of gastric mucosal bleeding | Improvement rate (%) = (Number of effective cases(change of ≥ 50% in bleeding score) / Number of target cases) x 100 | at 2 weeks after the IP administration |
| Improvement rate of subjective symptoms | Improvement rate (%) = (Number of effective cases(change of ≥ 50% in subjective symptom score) / Number of target cases) x 100 | at 2 weeks after the IP administration |