Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 2, Therapeutic Exploratory Study)
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.
1 other identifier
interventional
211
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2017
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2017
CompletedFirst Posted
Study publicly available on registry
June 12, 2017
CompletedStudy Start
First participant enrolled
August 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2018
CompletedSeptember 3, 2020
June 1, 2018
8 months
June 8, 2017
September 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Ratio of subjects who were completely cured of mucosal defects by 8 weeks
8 weeks
Secondary Outcomes (1)
Ratio of subjects who were completely cured of mucosal defects by 4 weeks
4 weeks
Study Arms (4)
DWP14012 20mg
EXPERIMENTALDWP14012 20mg, tablet, orally, once daily
DWP14012 40mg
EXPERIMENTALDWP14012 40mg, tablet, orally, once daily
DWP14012 80mg
EXPERIMENTALDWP14012 40mg\*2, tablet, orally, once daily
Esomerpazole 40mg
ACTIVE COMPARATOREsomerpazole 40mg, tablet, orally, once daily
Interventions
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 reflux 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
Sungdong-gu, Seoul, 04763, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
June 8, 2017
First Posted
June 12, 2017
Study Start
August 28, 2017
Primary Completion
April 18, 2018
Study Completion
April 18, 2018
Last Updated
September 3, 2020
Record last verified: 2018-06