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A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1903 in Patients with Gastritis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DW1903(Test) | Experimental | once a day, q.d. PO / DW1903 + Placebo of DW1903-R1 |
|
| DW1903-R1(Reference) | Active Comparator | once a day, q.d. PO / Placebo of DW1903 + DW1903-R1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DW1903 | Drug | q.d. PO, DW1903 + Placebo of DW1903-R1 |
| |
| DW1903-R1 |
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy rate on gastroscopy | The efficacy rate is obtained from the following formula using the subject whose erroneous score is improved by 50% or more as compared with before the study drug administration. The efficacy rate(%) = (number of effective cases)/(all cases) x 100 Effective case is determined by the grade change of erosion. A case in which the grade changes from 4 to 2 or 1, from 3 to 1, or from 2 to 1 is judged as an effective case. | Week 0, Week2 |
| Measure | Description | Time Frame |
|---|---|---|
| Cure rate on gastroscopy | Judging from the gastroscopic examination as normal (no erosion), the cure rate is obtained as follows. Cure rate(%) = (number of cures(no erosion))/(all cases) x 100 | Week 0, Week2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Seoul | 02841 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37309193 | Derived | Kim JH, Jung HY, Yoo IK, Park SY, Kim JG, Sung JK, Jang JS, Cheon GJ, Kim KO, Kim TO, Lee ST, Cho KB, Chun HJ, Park JJ, Park MI, Jang JY, Jeon SW, Cho JW, Kang DH, Kim GH, Kim JJ, Kim SG, Kim N, Lee YC, Hong SJ, Kim HS, Lee S, Lee SW. Evaluation of the Efficacy and Safety of DW1903 in Patients with Gastritis: A Randomized, Double-Blind, Noninferiority, Multicenter, Phase 3 study. Gut Liver. 2024 Jan 15;18(1):70-76. doi: 10.5009/gnl220446. Epub 2023 Jun 13. |
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There is no plan for IPD.
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Double (Participant, Investigator) Double-blind
| Drug |
q.d. PO, Placebo of DW1903 + DW1903-R1 |
|