Treatment Effect According to Timing of Administration of DWP14012 40 mg
The primary objective of this study is to establish noninferiority of efficacy of DWP14012 (40 mg once daily) based on Timing of Administration.
|Condition or Disease
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.
Arms and Interventions
|Experimental: fed state group
just after a meal
DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks
|Experimental: fasted state group
before a meal
DWP14012 40 mg, orally, once daily before a meal up to 4 weeks
Primary Outcome Measures
- healing rate at week 4 [up to 4 weeks]
Cumulative healing rate of erosive esophagitis at week 4 by endoscopy
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
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
Contacts and Locations
|Konkuk University Medical Center
|Korea, Republic of
Sponsors and Collaborators
- Konkuk University Medical Center
- Daewoong Pharmaceutical Co. LTD.
Study Documents (Full-Text)None provided.