Back to resultsStudy to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 2, Therapeutic Exploratory Study)
Primary Purpose
Erosive Gastroesophageal Reflux Disease
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWP14012
Esomeprazole
DWP14012 placebo
Esomeprazole placebo
Sponsored by
About this trial
This is an interventional treatment trial for Erosive Gastroesophageal Reflux Disease
Eligibility Criteria
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
Sites / Locations
- Hanyang University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
DWP14012 20mg
DWP14012 40mg
DWP14012 80mg
Esomerpazole 40mg
Arm Description
DWP14012 20mg, tablet, orally, once daily
DWP14012 40mg, tablet, orally, once daily
DWP14012 40mg*2, tablet, orally, once daily
Esomerpazole 40mg, tablet, orally, once daily
Outcomes
Primary Outcome Measures
Ratio of subjects who were completely cured of mucosal defects by 8 weeks
Secondary Outcome Measures
Ratio of subjects who were completely cured of mucosal defects by 4 weeks
Full Information
NCT ID
NCT03184324
First Posted
June 8, 2017
Last Updated
September 1, 2020
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT03184324
Brief Title
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 2, Therapeutic Exploratory Study)
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
April 18, 2018 (Actual)
Study Completion Date
April 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Gastroesophageal Reflux Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
211 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DWP14012 20mg
Arm Type
Experimental
Arm Description
DWP14012 20mg, tablet, orally, once daily
Arm Title
DWP14012 40mg
Arm Type
Experimental
Arm Description
DWP14012 40mg, tablet, orally, once daily
Arm Title
DWP14012 80mg
Arm Type
Experimental
Arm Description
DWP14012 40mg*2, tablet, orally, once daily
Arm Title
Esomerpazole 40mg
Arm Type
Active Comparator
Arm Description
Esomerpazole 40mg, tablet, orally, once daily
Intervention Type
Drug
Intervention Name(s)
DWP14012
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
DWP14012 placebo
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Esomeprazole placebo
Intervention Description
tablet
Primary Outcome Measure Information:
Title
Ratio of subjects who were completely cured of mucosal defects by 8 weeks
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Ratio of subjects who were completely cured of mucosal defects by 4 weeks
Time Frame
4 weeks
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:
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
Facility Information:
Facility Name
Hanyang University Medical Center
City
Sungdong-gu
State/Province
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 2, Therapeutic Exploratory Study)
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