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

NCT05163756 | Completed Phase 3

• 1 other identifier: DW1903-301
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gastritis Acute; Gastritis Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cure rate on gastroscopy

  Week 0, Week2

Study Arms (2)

DW1903(Test)

EXPERIMENTAL

once a day, q.d. PO / DW1903 + Placebo of DW1903-R1

Drug: DW1903

DW1903-R1(Reference)

ACTIVE COMPARATOR

once a day, q.d. PO / Placebo of DW1903 + DW1903-R1

Drug: DW1903-R1

Interventions

DW1903 DRUG

q.d. PO, DW1903 + Placebo of DW1903-R1

DW1903(Test)

DW1903-R1 DRUG

q.d. PO, Placebo of DW1903 + DW1903-R1

DW1903-R1(Reference)

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daewon Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Korea University Ansan Hospital

Seoul, 02841, South Korea

Location

Related Publications (1)

• Kim JH, Jung HY, Yoo IK, Park SY, Kim JG, Sung JK, Jang JS, Cheon GJ, Kim KO, Kim TO, Lee ST, Cho KB, Chun HJ, Park JJ, Park MI, Jang JY, Jeon SW, Cho JW, Kang DH, Kim GH, Kim JJ, Kim SG, Kim N, Lee YC, Hong SJ, Kim HS, Lee S, Lee SW. Evaluation of the Efficacy and Safety of DW1903 in Patients with Gastritis: A Randomized, Double-Blind, Noninferiority, Multicenter, Phase 3 study. Gut Liver. 2024 Jan 15;18(1):70-76. doi: 10.5009/gnl220446. Epub 2023 Jun 13.

  PMID: 37309193 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator) Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 20, 2021
• Study Start: November 25, 2020
• Primary Completion: April 27, 2021
• Study Completion: May 10, 2021
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)