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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
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. (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

    First Posted
    February 11, 2018
    Last Updated
    February 26, 2018
    Sponsor
    Daewon Pharmaceutical Co., Ltd.
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    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

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