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Gastroesophageal reflux disease (GERD) is a condition caused by the reflux of stomach contents into the esophagus, presenting with typical symptoms such as heartburn and acid regurgitation.
GERD is a chronic condition that affects quality of life, and patients with this condition are known to have a lower quality of life compared to healthy individuals. In particular, nocturnal heartburn can lead to sleep deprivation and affect daily life, as well as overall quality of life.
This study aims to evaluate the efficacy of alleviating nocturnal heartburn symptoms in patients with erosive reflux disease (ERD).
This multicenter, double-blind, randomized, active-controlled Phase 4 study aims to exploratorily evaluate the comparative effects and safety of zastaprazan 20 mg and esomeprazole 40 mg in subjects with gastroesophageal reflux disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zastaprazan | Experimental | Zastaprazan 20 mg, once daily, preferably administered orally in the morning before breakfast for four weeks |
|
| Esomeprazole | Active Comparator | Esomeprazole 40 mg, once daily, preferably administered orally in the morning before breakfast for four weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zastaprazan | Drug | Participants in this arm will receive zastaprazan. This group serves as the experimental treatment group exploratorily evaluating drug for GERD. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants without sleep disturbance related to nighttime heartburn during the last 7 days | This measure is based on participant-reported information collected by subject diary during the study and reflects whether sleep disturbance related to heartburn was noted over the period evaluated. Symptom severity ranges from 0 to 4, with higher scores indicating worse sleep disturbance. | Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants without sleep disturbance related to nighttime heartburn during the last 7 days | This measure is based on participant-reported information collected by subject diary during the study and reflects whether sleep disturbance related to heartburn was noted over the period evaluated. Symptom severity ranges from 0 to 4, with higher scores indicating worse sleep disturbance. | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Byung-Wook Kim | Contact | +82-1544-9004 | gastro@catholic.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Recruiting | Ansan | South Korea | |||
| Pusan National University Hospital |
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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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|
| Esomeprazole | Drug | Participants in this arm will receive esomeprazole. This group serves as the active comparator treatment group exploratorily evaluating drug for GERD. |
|
|
| Mean change from baseline in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score | The change from baseline in GERD-HRQL scores, evaluated at Weeks 2 and 4 during the treatment period. The GERD-HRQL uses item scores ranging from 0 to 5, with higher scores indicating more severe symptoms. | Baseline, Week 2, Week 4 |
| Mean change from baseline in Gastrointestinal Symptom Rating Scale (GSRS) score | The GSRS assesses gastrointestinal symptoms across multiple domains, with each item scored on a 1 to 7 scale, where higher scores indicate more severe symptoms. | Baseline, Week 2, Week 4 |
| Change from baseline in Gastroesophageal Reflux Disease Questionnaire (GerdQ) score | The GerdQ evaluates symptoms using ordinal item scores; for heartburn and acid regurgitation items, higher scores indicate more frequent symptoms; each item is scored on a 0 to 3 scale based on symptom frequency over the previous week, with reverse scoring applied to upper stomach pain and nausea items. | Baseline, Week 2, Week 4 |
| Recruiting |
| Busan |
| South Korea |
| Kyungpook National University Chilgok Hospital | Recruiting | Chilgok | South Korea |
| Hallym University Chuncheon Sacred Heart Hospital | Recruiting | Chuncheon | South Korea |
| Chonnam National University Hospital | Recruiting | Gwangju | South Korea |
| Catholic University of Korea, Incheon ST. Mary's Hospital | Recruiting | Incheon | South Korea |
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| Gangnam Severance Hospital | Recruiting | Seoul | South Korea |
| Kyung Hee University Hospital | Recruiting | Seoul | South Korea |
| Soonchunhyang University Hospital | Recruiting | Seoul | South Korea |
| Pusan National University Yangsan Hospital | Recruiting | Yangsan | South Korea |
| 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 |