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The purpose of this study is to evaluate treatment in Gastroesophageal Reflux Disease (GERD) patients (aged 18~75) with endoscopically proven GERD treated with AGSPT201 Tablet.
This study is 4,8 weeks, outpatient, multicenter, randomized, double-blinded, active drug comparative, therapeutic confirmatory clinical study to evaluate the efficacy and safety of AGSPT201 in erosive esophagitis patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-Pantoprazole | Experimental | Experimental drug: AGSPT201 Tab. (contain S-Patoprazole) Active comparator: Pantoloc Tab. (contain pantoprazole) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGSPT201 Tab contains S-pantoprazole | Drug | comparison of Pantoloc Tab 40mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with healing of erosive esophagitis(The absence of esophageal lesions) | Endoscopy is performed at baseline and 4 week. All patients whose esophageal lesions are graded (LA Grade A, B, C and D). The study is completed for the patients whose esophageal lesions are healed. However patients whose esophageal lesions are not healed at 4 week were treated for an additional 4 week with endoscopy repeated at 8 week. At 8 week, the study is completed regardless healing of esophageal lesions. | 4 week |
| Measure | Description | Time Frame |
|---|---|---|
| Absence and/or improvement of typical reflux symptoms | Patients recorded the improvement of typical reflux symptoms such as heartburn, acid regurgitation, acid reflux and esophagus irritation on diary card. The presence of symptoms are classified to absence (Score 0), mild (Score 1), moderate (Score 2), severe (Score 3) and very severe (Score 4). | 4 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MyoungKyu Choi, M.D | The Catholic University of Korea-St. Mary's Hospital | Principal Investigator |
| YoungTae Park, M.D. | Korea University Medical Center-Guro | Study Director |
| PoongRyul Lee, M.D | Samsung Medical Center | Study Director |
| SangKyun Kim, M.D | Seoul National University Hospital | Study Director |
| HoonYong Jeong, M.D | Asan Medical Center | Study Director |
| SangYoung Seol, M.D | Inje University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea St. Mary's Hospital | Seoul | Seoul | 137040 | South Korea |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |