Skip to main content
OpenTrials
Completed

NCT Number: NCT03443804

To Evaluate 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastritis Acute Gastritis Chronic

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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. (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.

Treatment and study plan

Test(DW1401)

Drug

DW1401+Placebo of Stillen tab.

Reference(Stillen tab.)

Drug

Stillen tab.+Placebo of DW1401

Primary outcomes

  1. The efficacy rate on gastroscopy

    Time frame: 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 outcomes

  1. Cure rate on gastroscopy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: 2

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 23, 2018
Registry last updated
Feb 28, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.