To Evaluate the Efficacy and Safety of DW1903 in Acute and Chronic Gastritis Patient
- Registration Number
- NCT05163756
- Lead Sponsor
- Daewon Pharmaceutical Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 332
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DW1903-R1(Reference) DW1903-R1 once a day, q.d. PO / Placebo of DW1903 + DW1903-R1 DW1903(Test) DW1903 once a day, q.d. PO / DW1903 + Placebo of DW1903-R1
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Korea University Ansan Hospital
🇰🇷Seoul, Korea, Republic of