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Phase 2a Study to Evaluate Optimum Dosage and Stability of DW-3101 in Gastric Inflammation Patients

Primary Purpose

Acute and Chronic Gastric Inflammation Patients

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
DW-3101_150mg
DW-3101_300mg
DW-3101_600mg
Placebo
Sponsored by
Daewon Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute and Chronic Gastric Inflammation Patients

Eligibility Criteria

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

Inclusion Criteria:

  • Adult males/females aged 20~75 years
  • Patients detected over 1 erosion who diagnosed as acute or chronic gastric inflammation by gastrscopy in 7days before administration of experimental agents
  • Subjects who voluntarily agree to participate in this clinical test with written consent

Exclusion Criteria:

  • Patients impossible gastroscopy
  • In case accompanied with gastric ulcer(scar excepted) or reflux esophagitis
  • Patients who had stomach or esophagus surgery to inhibit gastric acid secretion (tresis or appendicectomy surgery excluded)
  • Patients with malignant tumor on digestive organ
  • Patients with blood clot(cerebral thrombosis, myocardial infarction, septic thrombophlebitis) and who have antithrombotic agents (eg. warfarin)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    DW-3101_150mg

    DW-3101_300mg

    DW-3101_600mg

    a tablet same as experimental agents in formation and shape

    Arm Description

    150mg a day

    300mg a day

    600mg a day

    Placebo

    Outcomes

    Primary Outcome Measures

    The change of gastric erosion score
    The erosion score is evaluated by gastroscopy. Erosion score The number of erosion 0 1~2 3~5 More than 6 If patient's erosion score is decreased by 50% compared with erosion score before clinical dosing, we count it as effectiveness.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 16, 2015
    Last Updated
    October 11, 2016
    Sponsor
    Daewon Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02386007
    Brief Title
    Phase 2a Study to Evaluate Optimum Dosage and Stability of DW-3101 in Gastric Inflammation Patients
    Official Title
    A Double-blind, Multicenter, Randomized Phase 2a Study to Evaluate Optimum Dosage and Stability of DW-3101 in Korean Patients With Gastric Inflammation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    July 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to find optimum dosage of DW-3101 by evaluating efficacy and safety of each dosage group in Korean patients with acute and chronic gastric inflammation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute and Chronic Gastric Inflammation Patients

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    DW-3101_150mg
    Arm Type
    Experimental
    Arm Description
    150mg a day
    Arm Title
    DW-3101_300mg
    Arm Type
    Experimental
    Arm Description
    300mg a day
    Arm Title
    DW-3101_600mg
    Arm Type
    Experimental
    Arm Description
    600mg a day
    Arm Title
    a tablet same as experimental agents in formation and shape
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    DW-3101_150mg
    Intervention Type
    Drug
    Intervention Name(s)
    DW-3101_300mg
    Intervention Type
    Drug
    Intervention Name(s)
    DW-3101_600mg
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    The change of gastric erosion score
    Description
    The erosion score is evaluated by gastroscopy. Erosion score The number of erosion 0 1~2 3~5 More than 6 If patient's erosion score is decreased by 50% compared with erosion score before clinical dosing, we count it as effectiveness.
    Time Frame
    14day±3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult males/females aged 20~75 years Patients detected over 1 erosion who diagnosed as acute or chronic gastric inflammation by gastrscopy in 7days before administration of experimental agents Subjects who voluntarily agree to participate in this clinical test with written consent Exclusion Criteria: Patients impossible gastroscopy In case accompanied with gastric ulcer(scar excepted) or reflux esophagitis Patients who had stomach or esophagus surgery to inhibit gastric acid secretion (tresis or appendicectomy surgery excluded) Patients with malignant tumor on digestive organ Patients with blood clot(cerebral thrombosis, myocardial infarction, septic thrombophlebitis) and who have antithrombotic agents (eg. warfarin)

    12. IPD Sharing Statement

    Learn more about this trial

    Phase 2a Study to Evaluate Optimum Dosage and Stability of DW-3101 in Gastric Inflammation Patients

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