Erosive Esophagitis
Conditions
Brief summary
The primary objective of this study is to establish noninferiority of efficacy of DWP14012 (40 mg once daily) based on Timing of Administration.
Detailed description
Subjects will provide written informed consent for study participation and then undergo appropriate screening. Subjects who meet the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to either before meal group or after meal group. Subjects will be stratified into two groups according to Los Angeles classification grades (LA grades) A/B or C/D, as determined by upper gastrointestinal (GI) endoscopy.
Interventions
DRUGDWP14012
DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks
Sponsors
Daewoong Pharmaceutical Co. LTD.
Konkuk University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults between 19 and 75 years old based on the date of written agreement * Those who have been diagnosed with erosive esophagitis 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| healing rate at week 4 | up to 4 weeks | Cumulative healing rate of erosive esophagitis at week 4 by endoscopy |
Countries
South Korea
Contacts
Primary ContactSun Na
Outcome results
None listed