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OpenTrials
Completed

NCT Number: NCT05163756

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

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

Completed

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Key information

Conditions

Gastritis Acute Gastritis Chronic

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Korea University Ansan Hospital

Seoul, 02841, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DW1903

Drug

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

DW1903-R1

Drug

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

Primary outcomes

  1. The efficacy rate on gastroscopy

    Time frame: Week 0, Week2

    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 outcomes

  1. Cure rate on gastroscopy

    Time frame: Week 0, Week2

    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

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2021
Registry last updated
Dec 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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