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This study aims to compare the nighttime heartburn and sleep disturbance improvement effect of Tegoprazan 50mg and Eomeprazole 40mg in patients with ERD patients.
This is a multi-center, double-blind, randomized, active-controlled phase 4 (pilot) study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tegoprazan 50mg | Experimental | Tegoprazan 50mg tablet, once daily, oral administration |
|
| Esomeprazole 40mg | Active Comparator | Esomeprazole 40mg tablet, once daily, oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegoprazan | Drug | Tegoprazan 50mg tablet |
| |
| Esomeprazole |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first nighttime heartburn-free interval (days)) | Number of days to reach the without symptoms of nighttime heartburn after the start of drug administration for clinical trials. | 2 week |
| 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 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Kil Lee, Ph.D | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | 03722 | South Korea |
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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 40mg tablet |
|
| 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 |