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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
160
Participants in this arm will receive zastaprazan. This group serves as the experimental treatment group exploratorily evaluating drug for GERD.
Participants in this arm will receive esomeprazole. This group serves as the active comparator treatment group exploratorily evaluating drug for GERD.
Korea University Ansan Hospital
Ansan, South Korea
RECRUITINGPusan National University Hospital
Busan, South Korea
RECRUITINGKyungpook National University Chilgok Hospital
Chilgok, South Korea
RECRUITINGHallym University Chuncheon Sacred Heart Hospital
Chuncheon, South Korea
RECRUITINGChonnam National University Hospital
Gwangju, South Korea
RECRUITINGCatholic University of Korea, Incheon ST. Mary's Hospital
Incheon, South Korea
RECRUITINGGangnam Severance Hospital
Seoul, South Korea
RECRUITINGKyung Hee University Hospital
Seoul, South Korea
RECRUITINGSoonchunhyang University Hospital
Seoul, South Korea
RECRUITINGPusan National University Yangsan Hospital
Yangsan, South Korea
RECRUITINGProportion 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.
Time frame: Week 2
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.
Time frame: Week 4
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 2, Week 4
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