Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 2, Therapeutic Exploratory Study)
Phase 2
Completed
- Conditions
- Erosive Gastroesophageal Reflux Disease
- Interventions
- Registration Number
- NCT03184324
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 211
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DWP14012 40mg Esomeprazole placebo DWP14012 40mg, tablet, orally, once daily DWP14012 80mg Esomeprazole placebo DWP14012 40mg\*2, tablet, orally, once daily DWP14012 20mg DWP14012 DWP14012 20mg, tablet, orally, once daily DWP14012 20mg DWP14012 placebo DWP14012 20mg, tablet, orally, once daily DWP14012 20mg Esomeprazole placebo DWP14012 20mg, tablet, orally, once daily DWP14012 40mg DWP14012 DWP14012 40mg, tablet, orally, once daily DWP14012 40mg DWP14012 placebo DWP14012 40mg, tablet, orally, once daily DWP14012 80mg DWP14012 DWP14012 40mg\*2, tablet, orally, once daily DWP14012 80mg DWP14012 placebo DWP14012 40mg\*2, tablet, orally, once daily Esomerpazole 40mg DWP14012 placebo Esomerpazole 40mg, tablet, orally, once daily Esomerpazole 40mg Esomeprazole Esomerpazole 40mg, tablet, orally, once daily
- Primary Outcome Measures
Name Time Method Ratio of subjects who were completely cured of mucosal defects by 8 weeks 8 weeks
- Secondary Outcome Measures
Name Time Method Ratio of subjects who were completely cured of mucosal defects by 4 weeks 4 weeks
Trial Locations
- Locations (1)
Hanyang University Medical Center
🇰🇷Sungdong-gu, Seoul, Korea, Republic of