Treatment Effect According to Timing of Administration of DWP14012 40 mg
- Registration Number
- NCT04888819
- Lead Sponsor
- Konkuk University Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 186
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description fed state group DWP14012 just after a meal fasted state group DWP14012 before a meal
- Primary Outcome Measures
Name Time Method healing rate at week 4 up to 4 weeks Cumulative healing rate of erosive esophagitis at week 4 by endoscopy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of