Heartburn, Gastroesophageal Reflux Disease (GERD)

Incheon St.Mary's Hospital

Status and phase: Enrolling; Phase 4

Conditions: GERD

Treatments: Drug: Esomeprazole; Drug: Zastaprazan

Study type: Interventional

Funder types: Other

Identifiers

NCT07268820

JL-JAQ-402

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Zastaprazan

Experimental group

Description:

Zastaprazan 20 mg, once daily, preferably administered orally in the morning before breakfast for four weeks

Treatment:

Drug: Zastaprazan

Esomeprazole

Active Comparator group

Description:

Esomeprazole 40 mg, once daily, preferably administered orally in the morning before breakfast for four weeks

Treatment:

Drug: Esomeprazole