A Phase 3 interventional study of Test(DW1401) and Reference(Stillen tab.) in Gastritis Acute and Gastritis Chronic, sponsored by Daewon Pharmaceutical Co., Ltd.. Completed. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-02-28.
Sponsored by Daewon Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
Evaluate the Efficacy and Safety of DW1401 versus Stillen tab. in Patients with Acute or Chronic Gastritis
135 studies on the registry are indexed under Gastritis; 23 are open to participants now.
This study's enrollment of 462 is above the median of 200 across 97 interventional studies indexed under Gastritis.
Browse Gastritis studies →Daewon Pharmaceutical Co., Ltd. is the lead sponsor of 49 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
tid PO, DW1401+Placebo of Stillen tab.
Drug: Test(DW1401)
tid PO, Stillen tab.+Placebo of DW1401
Drug: Reference(Stillen tab.)
DW1401+Placebo of Stillen tab.
Stillen tab.+Placebo of DW1401
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.
Time frame: 0, week 2
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
Time frame: 0, week 2
No study locations are listed for this record.
Plan to share: No — There is no plan for IPD.
No publications or documents are linked to this record.
Ran from Jul 2014 to primary completion in Nov 2014, 4 months.
Of 11 phase 3 interventional studies under Gastritis, half reached primary completion within 6 months of starting (the median); a quarter within 4 and three quarters within 17. This study's 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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