Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3)
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
1 other identifier
interventional
263
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2018
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2018
CompletedFirst Posted
Study publicly available on registry
November 9, 2018
CompletedStudy Start
First participant enrolled
December 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2019
CompletedSeptember 3, 2020
September 1, 2020
8 months
October 26, 2018
September 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative healing rate of erosive esophagitis at 8week by endoscopy
at 8week
Secondary Outcomes (3)
Cumulative healing rate of erosive esophagitis at 4week by endoscopy
at 4week
Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)
at 4week and 8week
Quality of Life assessment using GERD-HRQL(GERD-Health related quality life)
at 4week and 8week
Study Arms (2)
DWP14012 40mg
EXPERIMENTALOrally, once daily
Esomeprazole 40mg
ACTIVE COMPARATOROrally, once daily
Interventions
DWP14012 40mg placebo-matching tablet, orally, once daily for up to 8 weeks
Esomeprazole 40mg tablet, orally, once daily for up to 8 weeks
Esomeprazole 40mg placebo-matching tablet, orally, once daily for up to 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hanyang University Medical Center
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2018
First Posted
November 9, 2018
Study Start
December 13, 2018
Primary Completion
August 7, 2019
Study Completion
August 7, 2019
Last Updated
September 3, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share