To Evaluate the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients (2)
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|ClinicalTrials.gov Identifier: NCT03443804|
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : February 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gastritis Acute Gastritis Chronic||Drug: Test(DW1401) Drug: Reference(Stillen tab.)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||462 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase 3 Clinical Trial to Evaluated the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients|
|Actual Study Start Date :||July 2014|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
tid PO, DW1401+Placebo of Stillen tab.
DW1401+Placebo of Stillen tab.
Active Comparator: Reference(Stillen tab.)
tid PO, Stillen tab.+Placebo of DW1401
Drug: Reference(Stillen tab.)
Stillen tab.+Placebo of DW1401
- The efficacy rate on gastroscopy [ Time Frame: 0, week 2 ]
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.
- Cure rate on gastroscopy [ Time Frame: 0, week 2 ]
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