To Evaluate the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients (2)
Primary Purpose
Gastritis Acute, Gastritis Chronic
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Test(DW1401)
Reference(Stillen tab.)
Sponsored by
About this trial
This is an interventional treatment trial for Gastritis Acute
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. (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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test(DW1401)
Reference(Stillen tab.)
Arm Description
tid PO, DW1401+Placebo of Stillen tab.
tid PO, Stillen tab.+Placebo of DW1401
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
NCT ID
NCT03443804
First Posted
February 11, 2018
Last Updated
February 26, 2018
Sponsor
Daewon Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03443804
Brief Title
To Evaluate the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients
Acronym
2
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the Efficacy and Safety of DW1401 versus Stillen tab. in Patients with Acute or Chronic 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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
462 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test(DW1401)
Arm Type
Experimental
Arm Description
tid PO, DW1401+Placebo of Stillen tab.
Arm Title
Reference(Stillen tab.)
Arm Type
Active Comparator
Arm Description
tid PO, Stillen tab.+Placebo of DW1401
Intervention Type
Drug
Intervention Name(s)
Test(DW1401)
Intervention Description
DW1401+Placebo of Stillen tab.
Intervention Type
Drug
Intervention Name(s)
Reference(Stillen tab.)
Intervention Description
Stillen tab.+Placebo of DW1401
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
0, week 2
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
0, week 2
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. (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.
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 DW-1401 in Acute and Chronic Gastritis Patients
We'll reach out to this number within 24 hrs