A Multicenter, Double-blind, Randomized Trial Comparing Zastaprazan 20 mg and Esomeprazole 40 mg for Night-time Heartburn Relief in Patients With Erosive Reflux Disease

What this Trial Is About

Gastroesophageal reflux disease (GERD) is a chronic condition caused by stomach contents flowing back into the esophagus, leading to symptoms like heartburn and acid regurgitation. This condition often reduces quality of life, especially when night-time heartburn disrupts sleep and daily activities. The research aims to evaluate how well two treatments relieve night-time heartburn symptoms in patients with erosive reflux disease (ERD). This multicenter, double-blind, randomized Phase 4 study compares the effects and safety of two drugs: zastaprazan 20 mg and esomeprazole 40 mg. Participants receive one of these treatments once daily, preferably in the morning before breakfast, for four weeks. The study is designed to explore how each drug alleviates symptoms of GERD, especially night-time heartburn. Participants will be monitored through various assessments, including tracking sleep disturbances related to night-time heartburn during the last week of treatment at weeks 2 and 4. Additional evaluations include changes in quality of life and gastrointestinal symptom scores at the start, week 2, and week 4. The study measures the proportion of participants without sleep disturbance due to heartburn and assesses overall symptom relief to determine the effects of the treatments over the four-week period.

Heartburn, Gastroesophageal Reflux Disease