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

Primary Purpose

Gastritis Acute, Gastritis Chronic

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DW1903
DW1903-R1
Sponsored by
Daewon Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastritis Acute

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Korea University Ansan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DW1903(Test)

DW1903-R1(Reference)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 7, 2021
Last Updated
December 7, 2021
Sponsor
Daewon Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05163756
Brief Title
To Evaluate the Efficacy and Safety of DW1903 in Acute and Chronic Gastritis Patient
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
April 27, 2021 (Actual)
Study Completion Date
May 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewon Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastritis Acute, Gastritis Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double (Participant, Investigator) Double-blind
Allocation
Randomized
Enrollment
332 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DW1903(Test)
Arm Type
Experimental
Arm Description
once a day, q.d. PO / DW1903 + Placebo of DW1903-R1
Arm Title
DW1903-R1(Reference)
Arm Type
Active Comparator
Arm Description
once a day, q.d. PO / Placebo of DW1903 + DW1903-R1
Intervention Type
Drug
Intervention Name(s)
DW1903
Intervention Description
q.d. PO, DW1903 + Placebo of DW1903-R1
Intervention Type
Drug
Intervention Name(s)
DW1903-R1
Intervention Description
q.d. PO, Placebo of DW1903 + DW1903-R1
Primary Outcome Measure Information:
Title
The efficacy rate on gastroscopy
Description
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.
Time Frame
Week 0, Week2
Secondary Outcome Measure Information:
Title
Cure rate on gastroscopy
Description
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
Time Frame
Week 0, Week2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan for IPD.

Learn more about this trial

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

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