Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 2, Therapeutic Exploratory Study)

Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Completed
CT.gov ID
NCT03184324
Collaborator
(none)
211
1
4
7.7
27.6

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the efficacy and safety of DWP14012 compared to esomeprazole in the treatment of erosive gastroesophageal reflux disease classified as Los Angeles(LA) classification grades A to D.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
211 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multi-Center, Randomized, Double-Blind, Active-controlled, Phase 2, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease.
Actual Study Start Date :
Aug 28, 2017
Actual Primary Completion Date :
Apr 18, 2018
Actual Study Completion Date :
Apr 18, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: DWP14012 20mg

DWP14012 20mg, tablet, orally, once daily

Drug: DWP14012
tablet

Drug: DWP14012 placebo
tablet

Drug: Esomeprazole placebo
tablet

Experimental: DWP14012 40mg

DWP14012 40mg, tablet, orally, once daily

Drug: DWP14012
tablet

Drug: DWP14012 placebo
tablet

Drug: Esomeprazole placebo
tablet

Experimental: DWP14012 80mg

DWP14012 40mg*2, tablet, orally, once daily

Drug: DWP14012
tablet

Drug: DWP14012 placebo
tablet

Drug: Esomeprazole placebo
tablet

Active Comparator: Esomerpazole 40mg

Esomerpazole 40mg, tablet, orally, once daily

Drug: Esomeprazole
tablet
Other Names:
  • Nexium
  • Drug: DWP14012 placebo
    tablet

    Outcome Measures

    Primary Outcome Measures

    1. Ratio of subjects who were completely cured of mucosal defects by 8 weeks [8 weeks]

    Secondary Outcome Measures

    1. Ratio of subjects who were completely cured of mucosal defects by 4 weeks [4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adults between 20 and 75 years old based on the date of written agreement

    • Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy

    • Those who experienced symptoms of heartburn or acid reflux within the last 7 days

    Exclusion Criteria:
    • Those who have undergone gastric acid suppression or gastric, esophageal surgery

    • Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hanyang University Medical Center Sungdong-gu Seoul Korea, Republic of 04763

    Sponsors and Collaborators

    • Daewoong Pharmaceutical Co. LTD.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daewoong Pharmaceutical Co. LTD.
    ClinicalTrials.gov Identifier:
    NCT03184324
    Other Study ID Numbers:
    • DW_DWP14012002
    First Posted:
    Jun 12, 2017
    Last Update Posted:
    Sep 3, 2020
    Last Verified:
    Jun 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 3, 2020