Erosive Gastroesophageal Reflux Disease
Conditions
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.
Interventions
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of subjects who were completely cured of mucosal defects by 8 weeks | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Ratio of subjects who were completely cured of mucosal defects by 4 weeks | 4 weeks |
Countries
South Korea
Outcome results
None listed