To Evaluate the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients (2)

Daewon Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Gastritis Chronic

Gastritis Acute

Treatments

Drug: Reference(Stillen tab.)

Drug: Test(DW1401)

Study type

Interventional

Funder types

Industry

Identifiers

DW1401-302

Details and patient eligibility

About

Evaluate the Efficacy and Safety of DW1401 versus Stillen tab. in Patients with Acute or Chronic Gastritis

Enrollment

462 patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

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.