Heartburn, Gastroesophageal Reflux Disease

NCT07268820 | Recruiting Phase 4

• 1 other identifier: JL-JAQ-402
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 10

Brief 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).

Conditions

GERD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Proportion of participants without sleep disturbance related to nighttime heartburn during the last 7 days

  Week 4

• Mean change from baseline in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score

  Baseline, Week 2, Week 4

• Mean change from baseline in Gastrointestinal Symptom Rating Scale (GSRS) score

  Baseline, Week 2, Week 4

• Change from baseline in Gastroesophageal Reflux Disease Questionnaire (GerdQ) score

  Baseline, Week 2, Week 4

Study Arms (2)

Zastaprazan

EXPERIMENTAL

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

Drug: Zastaprazan

Esomeprazole

ACTIVE COMPARATOR

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

Drug: Esomeprazole

Interventions

Zastaprazan DRUG

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

Also known as: P-CAB

Zastaprazan

Esomeprazole DRUG

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

Also known as: PPI

Esomeprazole

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Incheon St.Mary's Hospital: lead

Study Sites (10)

Korea University Ansan Hospital

Ansan, South Korea

RECRUITING

Pusan National University Hospital

Busan, South Korea

RECRUITING

Kyungpook National University Chilgok Hospital

Chilgok, South Korea

RECRUITING

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

Catholic University of Korea, Incheon ST. Mary's Hospital

Incheon, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

Kyung Hee University Hospital

Seoul, South Korea

RECRUITING

Soonchunhyang University Hospital

Seoul, South Korea

RECRUITING

Pusan National University Yangsan Hospital

Yangsan, South Korea

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Byung-Wook Kim

CONTACT

+82-1544-9004; gastro@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (10)