Heartburn, Gastroesophageal Reflux Disease (GERD)

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

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).

Study Overview

• Status: Recruiting
• Conditions: GERD
• Intervention / Treatment: Drug: Zastaprazan; Drug: Esomeprazole

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Byung-Wook Kim; Phone Number: +82-1544-9004; Email: gastro@catholic.ac.kr

Study Locations

• South Korea
  • Ansan, South Korea
    • Recruiting
    • Korea University Ansan Hospital
  • Busan, South Korea
    • Recruiting
    • Pusan National University Hospital
  • Chilgok, South Korea
    • Recruiting
    • Kyungpook National University Chilgok Hospital
  • Chuncheon, South Korea
    • Recruiting
    • Hallym University Chuncheon Sacred Heart Hospital
  • Gwangju, South Korea
    • Recruiting
    • Chonnam National University Hospital
  • Incheon, South Korea
    • Recruiting
    • Catholic University of Korea, Incheon ST. Mary's Hospital
    • Contact: Byung-Wook Kim; Phone Number: 82-2-1544-9004; Email: gastro@catholic.ac.kr
  • Seoul, South Korea
    • Recruiting
    • Gangnam Severance Hospital
  • Seoul, South Korea
    • Recruiting
    • Kyung Hee University Hospital
  • Seoul, South Korea
    • Recruiting
    • Soonchunhyang University Hospital
  • Yangsan, South Korea
    • Recruiting
    • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zastaprazan; Zastaprazan 20 mg, once daily, preferably administered orally in the morning before breakfast for four weeks	Drug: Zastaprazan; Participants in this arm will receive zastaprazan. This group serves as the experimental treatment group exploratorily evaluating drug for GERD.; Other Names: P-CAB
Active Comparator: Esomeprazole; Esomeprazole 40 mg, once daily, preferably administered orally in the morning before breakfast for four weeks	Drug: Esomeprazole; Participants in this arm will receive esomeprazole. This group serves as the active comparator treatment group exploratorily evaluating drug for GERD.; Other Names: PPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Incheon St.Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2025
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Estimated): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Omeprazole; Esomeprazole
• Other Study ID Numbers: JL-JAQ-402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No