Gastritis Acute, Gastritis Chronic
Conditions
Brief summary
Evaluate the Efficacy and Safety of DW1401 versus Stillen tab. in Patients with Acute or Chronic Gastritis
Interventions
DRUGTest(DW1401)
DW1401+Placebo of Stillen tab.
DRUGReference(Stillen tab.)
Stillen tab.+Placebo of DW1401
Sponsors
Daewon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who were diagnosed with acute or chronic gastritis in a gastroscopy performed within 7 days prior to administration of this trial. * At least one or more erosions have been identified on gastroscopy. * Patients who decided to voluntarily participate in this trial and agreed in writing.
Exclusion criteria
* Patients who can not undergo gastroscopy * Peptic ulcer (except scarring) and reflux esophagitis * Patients who have had gastric acid suppression surgery or stomach/esophagus surgery (except for simple perforation surgery and appendectomy) * Patients with a history of gastrointestinal malignancies * Zollinger-Ellison syndrome patients * Patient with spontaneous coagulation disorder * Patients with an allergic or hypersensitive response to a study drug * Patients with a potential pregnancy. * Patients who had clinically significant abnormalities in the screening test. (ALT, AST, BUN, Serum creatinine is more than twice the upper limit) * Pregnant and lactating women * Those currently taking other study drugs * patients who were judged to be ineligible for the trial by the principle investigator and the person in charge.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy rate on gastroscopy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cure rate on gastroscopy | 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 |
Outcome results
None listed