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

Gastritis Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05163756
• Other study ID #: DW1903-301
• Status: Completed
• Phase: Phase 3
• Start date: November 25, 2020
• Est. completion date: May 10, 2021

Study information

• Verified date: December 2021
• Source: Daewon Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: May 10, 2021
• Est. primary completion date: April 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastritis
• Gastritis Acute
• Gastritis Chronic

Intervention

Drug:
• DW1903
q.d. PO, DW1903 + Placebo of DW1903-R1
• DW1903-R1
q.d. PO, Placebo of DW1903 + DW1903-R1

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 0, Week2
Secondary	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	Week 0, Week2