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The purpose of this study is to demonstrate the superiority of efficacy of DWP14012, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4.
This is a multi-center, double blind, randomized, placebo-controlled, parallel-group, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (DWP14012 A mg or DWP14012 B mg or placebo).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWP14012 A mg | Experimental | DWP14012 A mg, tablet, once daily, oral administration for up to 4 weeks |
|
| DWP14012 B mg | Experimental | DWP14012 B mg, tablet, once daily, oral administration for up to 4 weeks |
|
| Placebo | Placebo Comparator | Placebo, tablet, once daily, oral administration for up to 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP14012 A mg | Drug | The participants will receive treatment of DWP14012 A mg, tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Percentage of patients with complete resolution of major symptoms (heartburn and acid regurgitation) at 4-week | defined as no episodes of symptom during the last 7 days of treatment, using Reflux Disease Questionnaire(RDQ) | 4 week |
| Measure | Description | Time Frame |
|---|---|---|
| Reflux disease symptom assessment using RDQ(Reflux disease questionnaire) | 2 week, 4 week | |
| Reflux disease symptom assessment using Subject diary | 4 week | |
| Quality of Life assessment using PAGI-QoL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daewoong Pharmaceutical Co. LTD. | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University Medical Center | Recruiting | Seoul | South Korea |
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| DWP14012 B mg | Drug | The participants will receive treatment of DWP14012 B mg, tablet, orally, once daily and DWP14012 A mg placebo-matching tablet, orally, once daily for up to 4 weeks. |
|
| Placebo | Drug | The participants will receive treatment of DWP14012 A mg placebo-matching tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 weeks. |
|
| 4 week |
| Use of rescue medication | 4 week |