Back to resultsStudy to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3)
Primary Purpose
Erosive Esophagitis
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWP14012 40mg
DWP14012 40mg placebo
Esomeprazole 40mg
Esomeprazole 40mg placebo
Sponsored by
About this trial
This is an interventional treatment trial for Erosive Esophagitis
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 regurgitation 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 Type
Experimental
Active Comparator
Arm Label
DWP14012 40mg
Esomeprazole 40mg
Arm Description
Orally, once daily
Orally, once daily
Outcomes
Primary Outcome Measures
Cumulative healing rate of erosive esophagitis at 8week by endoscopy
Secondary Outcome Measures
Cumulative healing rate of erosive esophagitis at 4week by endoscopy
Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)
Mean change of the frequency or severity of main symptoms
Quality of Life assessment using GERD-HRQL(GERD-Health related quality life)
Mean change of the total score of GERD-HRQL
Full Information
NCT ID
NCT03736369
First Posted
October 26, 2018
Last Updated
September 1, 2020
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT03736369
Brief Title
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3)
Official Title
A Multi-Center, Randomized, Double-Blind, Active-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory 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
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 13, 2018 (Actual)
Primary Completion Date
August 7, 2019 (Actual)
Study Completion Date
August 7, 2019 (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 study is to confirm the efficacy of DWP14012 Xmg, Once daily, compared to esomeprazole 40mg in patients with erosive gastroesophageal reflux disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Esophagitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
263 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DWP14012 40mg
Arm Type
Experimental
Arm Description
Orally, once daily
Arm Title
Esomeprazole 40mg
Arm Type
Active Comparator
Arm Description
Orally, once daily
Intervention Type
Drug
Intervention Name(s)
DWP14012 40mg
Intervention Description
DWP14012 40mg, tablet, orally, once daily for up to 8 weeks
Intervention Type
Drug
Intervention Name(s)
DWP14012 40mg placebo
Intervention Description
DWP14012 40mg placebo-matching tablet, orally, once daily for up to 8 weeks
Intervention Type
Drug
Intervention Name(s)
Esomeprazole 40mg
Other Intervention Name(s)
Nexium 40mg
Intervention Description
Esomeprazole 40mg tablet, orally, once daily for up to 8 weeks
Intervention Type
Drug
Intervention Name(s)
Esomeprazole 40mg placebo
Other Intervention Name(s)
Nexium 40mg placebo
Intervention Description
Esomeprazole 40mg placebo-matching tablet, orally, once daily for up to 8 weeks
Primary Outcome Measure Information:
Title
Cumulative healing rate of erosive esophagitis at 8week by endoscopy
Time Frame
at 8week
Secondary Outcome Measure Information:
Title
Cumulative healing rate of erosive esophagitis at 4week by endoscopy
Time Frame
at 4week
Title
Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)
Description
Mean change of the frequency or severity of main symptoms
Time Frame
at 4week and 8week
Title
Quality of Life assessment using GERD-HRQL(GERD-Health related quality life)
Description
Mean change of the total score of GERD-HRQL
Time Frame
at 4week and 8week
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 regurgitation 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
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3)
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