Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to demonstrate the noninferiority of DWP14012 to Lansoprazole 15 mg in the maintenance effect of treatment and confirm the safety of DWP14012 in patients with healed erosive esophagitis confirmed on EGD after medication treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWP14012 20mg | Experimental | Orally, once daily |
|
| Lansoprazole 15mg | Active Comparator | Orally, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP14012 20 mg | Drug | DWP14012 20 mg, tablet, orally, once daily for up to 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 24 | at 24 week |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 12 | at 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| GERD-Health related quality life(HRQL) | Changes from baseline in the total score of GERD-HRQL at Weeks 4, 12, and 24(The total score could range from 0 to 50 and lower score was evaluated as higher quality of life) | at Weeks 4, 12, and 24 |
| Assessment on symptoms |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oh-Young Lee | Contact | 82-2-2290-8637 | leeoy@hanyang.ac.kr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Yeouido ST. Mary's Hospital | Recruiting | Seoul | 07345 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
| DWP14012 20 mg placebo |
| Drug |
DWP14012 20 mg placebo-matching tablet, orally, once daily for up to 24 weeks |
|
| Lansoprazole 15 mg | Drug | Lansoprazole 15 mg capsule, orally, once daily for up to 24 weeks |
|
| Lansoprazole 15 mg Placebo | Drug | Lansoprazole 15 mg Placebo capsule, orally, once daily for up to 24 weeks |
|
Proportions of subjects without the major symptoms (heartburn and/or acid regurgitation) at Weeks 4, 12, and 24 |
| Weeks 4, 12, and 24 |
| ID | Term |
|---|---|
| C000634065 | fexuprazan |
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided