Gastritis Acute, Gastritis Chronic
Conditions
Brief summary
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
Interventions
Sponsors
Daewon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant, Investigator) Double-blind
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. * 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 | Week 0, Week2 | 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 | Week 0, Week2 | 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 |
Countries
South Korea
Outcome results
None listed