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

Phase 3

Completed

• Conditions: Gastritis Chronic; Gastritis Acute
• Interventions: Drug: Test(DW1401); Drug: Reference(Stillen tab.)

• Registration Number: NCT03443804
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2018-02
• Study First Submitted: 2018-02-11
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-23
• Last Update Submitted: 2018-02-26
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 462

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test(DW1401)	Test(DW1401)	tid PO, DW1401+Placebo of Stillen tab.
Reference(Stillen tab.)	Reference(Stillen tab.)	tid PO, Stillen tab.+Placebo of DW1401

Primary Outcome Measures

Name	Time	Method
The efficacy rate on gastroscopy	0, week 2	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	0, week 2	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