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Clinical trial to evaluate the safety and efficacy of JP-1366 in patients with erosive gastroesophageal reflux disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | JP-1366 A mg |
|
| Group 2 | Experimental | JP-1366 B mg |
|
| Group 3 | Experimental | JP-1366 C mg |
|
| Goup 4 | Active Comparator | Esomeprazole 40 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JP-1366 | Drug | JP-1366, QD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Accumulated mucosal defect cure rate*(%) at Week 8 following study drug administration (%) | * Erosion recovered to normal mucous membrane on upper gastrointestinal endoscopy | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital and 19 hospitals | Seoul | South Korea |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| JP-1366 placebo |
| Drug |
JP-1366 placebo, QD |
|
| Esomeprazole 40mg | Drug | Esomeprazole 40mg, QD |
|
| Esomeprazole placebo | Drug | Esomeprazole placebo, QD |
|
| D004066 | Digestive System Diseases |
| 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 |