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This study aims to compare the nighttime heartburn improvement effect of Tegoprazan 50mg and Esomeprazole 40mg(or 20mg) in patients with GERD.
This is a multi-center, double-blind, randomized, active-controlled phase 4 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg or 20mg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tegoprazan 50mg | Experimental | Tegoprazan 50mg, once daily, oral administration for two weeks |
|
| Esomeprazole 40mg or 20mg | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegoprazan | Drug | Tegoprazan 50mg tablet |
| |
| Esomeprazole |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of days without nighttime heartburn during the 2-week dosing period | Percentage of days without nighttime heartburn = Number of days without nighttime heartburn symptoms during the dosing period / Number of days when nighttime heartburn was assessed x 100 | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first nighttime hearturn-free interval(days) | Number of days to reach the first day without symptoms of nighttime heartburn after the administration of investigational drug | 2 weeks |
| Percentage of days without daytime heartburn during the 2-week dosing period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tae Hoon Kim | Contact | 82-2-6477-0244 | luke.kim@inno-n.com | |
| Jong Min Lee | Contact | 82-2-6477-0251 | jongmin.lee6@inno-n.com |
| Name | Affiliation | Role |
|---|---|---|
| Sang Kil Lee, Ph.D | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Recruiting | Seoul | 03722 | 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 |
|---|---|
| C000631239 | tegoprazan |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Drug |
Esomeprazole 20mg tablet
|
|
Percentage of days without daytime heartburn = Number of days without daytime heartburn symptoms during the dosing period / Number of days when daytime heartburn was assessed x 100 |
| 2 weeks |
| 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 |