A Multi-Center, Open-label, Randomized Trial to Evaluate the Efficacy and Safety Based on Timing of Administration of DWP14012 in Patients With Erosive Esophagitis
| Registry | NCT04613895 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 186 (Estimated) |
| Sponsor | Daewoong Pharmaceutical Co. LTD. (Industry); collaborators: Hanyang University |
| Conditions | Erosive Esophagitis |
| Interventions | DWP14012 (Drug) |
| Dates | start 2020-11-17 (estimated), primary completion 2021-05-30 (estimated), completion 2021-12-30 (estimated), first posted 2020-11-03, last updated 2020-11-03 |
| Locations | 1 site in South Korea |
Related Papers Related Patents Related Grants Related Experts
All trials for Erosive Esophagitis All trials of DWP14012
The primary objective of this study is to establish noninferiority of efficacy of DWP14012 (40 mg once daily) based on Timing of Administration.
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. Subjects will visit the site at Week 2 for endoscopic assessment. Subjects whose mucosal breaks have completely healed will be prematurely withdrawn and considered to have reached end of treatment. Subjects whose mucosal breaks have not healed will continue to receive IPs for an additional 2 weeks and will visit the site for endoscopic assessment at Week 4.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| fed state group | Experimental | Drug: DWP14012 | just after a meal |
| fasted state group | Experimental | Drug: DWP14012 | before a meal |
Sex: All, ages: 19 Years to 75 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Hanyang University Medical Center | Seoul | South Korea |