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

NCT ID: NCT03443804

Last Updated: 2018-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 462 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-11-30

Brief Summary

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

Conditions

Gastritis Acute; Gastritis Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Test(DW1401)

tid PO, DW1401+Placebo of Stillen tab.

Group Type: EXPERIMENTAL

Test(DW1401)

Intervention Type: DRUG

DW1401+Placebo of Stillen tab.

Reference(Stillen tab.)

tid PO, Stillen tab.+Placebo of DW1401

Group Type: ACTIVE_COMPARATOR

Reference(Stillen tab.)

Intervention Type: DRUG

Stillen tab.+Placebo of DW1401

Interventions

Test(DW1401)

DW1401+Placebo of Stillen tab.

Intervention Type: DRUG

Reference(Stillen tab.)

Stillen tab.+Placebo of DW1401

Intervention Type: DRUG

Eligibility 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. (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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daewon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

DW1401-302

Identifier Type: -

Identifier Source: org_study_id