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

A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase 3 Clinical Trial to Evaluated the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients

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

Study Overview

• Status: Completed
• Conditions: Gastritis Acute; Gastritis Chronic
• Intervention / Treatment: Drug: Test(DW1401); Drug: Reference(Stillen tab.)

• Study Type: Interventional
• Enrollment (Actual): 462
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test(DW1401); tid PO, DW1401+Placebo of Stillen tab.	Drug: Test(DW1401); DW1401+Placebo of Stillen tab.
Active Comparator: Reference(Stillen tab.); tid PO, Stillen tab.+Placebo of DW1401	Drug: Reference(Stillen tab.); Stillen tab.+Placebo of DW1401

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The efficacy rate on gastroscopy	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.	0, week 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cure rate on gastroscopy	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	0, week 2

Collaborators and Investigators

• Sponsor: Daewon Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: February 11, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 26, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis
• Other Study ID Numbers: DW1401-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan for IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No