RecruitingPhase 4NCT07268820

Heartburn, Gastroesophageal Reflux Disease

A Multicenter, Double-blind, Randomized, Investigator-initiated Trial to Evaluate the Degree of Symptom Relief of Zastaprazan and Esomeprazole in Patients With Erosive Reflux Disease With Night-time Heartburn Symptoms

Sponsor

Incheon St.Mary's Hospital

Enrollment

160 participants

Start Date

Jul 7, 2025

Study Type

INTERVENTIONAL

Conditions

GERD

Summary

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).

Eligibility

Min Age: 19 Years

Inclusion Criteria4

Korean adults aged 19 years or older as of the date of written consent
Those diagnosed with erosive gastroesophageal reflux disease based on upper gastrointestinal endoscopy (EGD)
Those who reported nighttime heartburn for more than 3 months at the time of screening (Visit 1)
Those who voluntarily decided to participate and provide written informed consent

Exclusion Criteria4

Those who cannot undergo upper gastrointestinal endoscopy (EGD)
Individuals with a history of drug or alcohol abuse (within the past year)
Individuals who have received other investigational products within one month prior to the screening visit (Visit 1)
In addition to the above, individuals with clinically significant findings that the investigator deems medically inappropriate for the present study

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Interventions

DRUGZastaprazan

Participants in this arm will receive zastaprazan. This group serves as the experimental treatment group exploratorily evaluating drug for GERD.

DRUGEsomeprazole

Participants in this arm will receive esomeprazole. This group serves as the active comparator treatment group exploratorily evaluating drug for GERD.