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To Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg
A multicenter, randomized, double-blind, active-controlled phase 4 study to evaluate the efficacy and safety of EsoDuo Tab. 20/800mg in patients with non-erosive reflux disease(NERD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EsoDuo Tab. 20/800mg | Experimental | EsoDuo Tab. 20/800mg |
|
| Nexium Tab. 20mg | Active Comparator | Nexium Tab. 20mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EsoDuo Tab. 20/800mg | Drug | Nexium Tab. 20mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete resolution of heartburn(HB), Last 7 days of treatment, 4 weeks. | Compare Experimental group with Active Comparator. | 4 weeks after drug administrations. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete resolution of heartburn(HB), Last 7 days of treatment, 2 weeks. | Compare Experimental group with Active Comparator. | 2 weeks after drug administrations |
| Complete resolution of Acid regurgitation, Last 7 days of treatment, 2 / 4 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oh Young Lee, M.D., Ph.D. | Hanyang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-A University Hospital | Busan | South Korea | ||||
| Kosin University Gospel Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35730245 | Derived | Park SH, Lee KN, Lee OY, Choi MG, Kim JH, Sung IK, Jang JY, Park KS, Chun HJ, Kim EY, Lee JK, Jang JS, Kim GH, Hong SJ, Lee YC, Choi SC, Kim HS, Kim TO, Baik GH, Jeon YC. A Randomized, Double-Blind, Active-Control, Noninferiority, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of Esomeprazole/Sodium Bicarbonate 20/800 mg in Patients with Nonerosive Gastroesophageal Reflux Disease. Gut Liver. 2023 Mar 15;17(2):226-233. doi: 10.5009/gnl220023. Epub 2022 Jun 22. |
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Compare Experimental group with Active Comparator.
| 2/4 weeks after drug administrations. |
| The percentage of Heartburn(HB) / Acid regurgitation only 1 day or less free days, 2 / 4 weeks. | Compare Experimental group with Active Comparator. | 2/4 weeks after drug administrations. |
| The percentage of free days without Heartburn(HB) / Acid regurgitation, 2 / 4 weeks. | Compare Experimental group with Active Comparator. | 2/4 weeks after drug administrations. |
| The time to the first 24/48-h, 7-d of Heartburn(HB) / Acid regurgitation free interval. | Compare Experimental group with Active Comparator. | 2/4 weeks after drug administrations. |
| Change from baseline in the Heartburn(HB) / Acid regurgitation Symptom score, 2 / 4 weeks. | Compare Experimental group with Active Comparator. | 2/4 weeks after drug administrations. |
| Heartburn(HB) / Acid regurgitation symptoms per investigator assessment, 4weeks. | Compare Experimental group with Active Comparator. | 4 weeks after drug administrations. |
| Time to first resolution of Heartburn(HB), Day 1 | Compare Experimental group with Active Comparator. | 1 day after drug administrations. |
| Busan |
| South Korea |
| Soonchunhyang University Cheonan Hospital | Cheonan | South Korea |
| Chungbuk National University Hospital | Cheongju-si | South Korea |
| Hallym University Chuncheon Seonsim Hospital | Chuncheon | South Korea |
| Daegu Catholic Hospital | Daegu | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | South Korea |
| Yeungnam University Medicar Center | Daegu | South Korea |
| Chungnam National University Hospital | Daejeon | South Korea |
| Myongji Hospital | Goyang | South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| Ajou University Hospital | Gyeonggi-do | South Korea |
| Hanyang University Guri Hospital | Gyeonggi-do | South Korea |
| Inje University ilsan Paik Hospital | Gyeonggi-do | South Korea |
| Soonchunhyang University Bucheon Hospital | Gyeonggi-do | South Korea |
| Wonkwang University Hospital | Iksan | South Korea |
| Dongguk University IIsan Hospital | Ilsan | South Korea |
| Gachon Gil Hospital | Incheon | South Korea |
| Jeju National University Hospital | Jeju City | South Korea |
| Chonbuk National University Hospital | Jeonju | South Korea |
| Inje University Busan Paik Hospital | Pusan | South Korea |
| Inje University Haeundae Paik Hospital | Pusan | South Korea |
| Pusan National University Hospital | Pusan | South Korea |
| Yangsan Pusan National University Hospital | Pusan | South Korea |
| Asan Medical Center, Seoul | Seoul | South Korea |
| Catholic University Seoul St. Mary's Hospital | Seoul | South Korea |
| Chung Ang University Hospital | Seoul | South Korea |
| Gangnam Severance | Seoul | South Korea |
| Hanyang University Hospital | Seoul | South Korea |
| Konkuk University Hospital | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Kyunghee Universtiy Hospital | Seoul | South Korea |
| Samsung Seoul Hospital | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| Soonchunhyang University Seoul Hospital | Seoul | South Korea |
| Wonju Severance Christian Hospital | Wŏnju | South Korea |
| ID | Term |
|---|---|
| D000096663 | Non-Erosive Reflux Disease |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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