To Evaluate the Efficacy and Safety of DW1903 in Acute and Chronic Gastritis Patient

• Status: Completed
• Trial end date: 2021-05-10
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Criteria

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.