Nighttime heartburn treatment for people with erosive 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
This study will try zastaprazan 20 mg versus esomeprazole 40 mg to see if either reduces nighttime heartburn in adults with erosive reflux disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Incheon St.Mary's Hospital Academic / other |
| Locations | 10 sites (Ansan and 9 other locations) |
| Trial ID | NCT07268820 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, double-blind, randomized, active-controlled Phase 4 trial comparing zastaprazan 20 mg and esomeprazole 40 mg in adults with erosive gastroesophageal reflux disease who report nocturnal heartburn for more than three months. Eligible participants must have ERD confirmed by upper gastrointestinal endoscopy and will be randomized to one of the two blinded treatment arms. Nighttime heartburn symptoms and safety outcomes will be tracked through regular clinic visits and symptom reporting during the treatment period. Safety monitoring and adverse event assessments will be performed throughout the study.
Who should consider this trial
Good fit: Adults in Korea aged 19 or older with endoscopy-confirmed erosive reflux disease who have had nighttime heartburn for more than three months and who can undergo endoscopy and give informed consent.
Not a fit: People without erosive reflux disease (non-erosive reflux), those unable to undergo endoscopy, recent users of other investigational drugs, or individuals with recent substance abuse or other medical conditions deemed unsafe by the investigator may not benefit or be eligible for this study.
Why it matters
Potential benefit: If successful, the test could provide better nighttime symptom relief, improve sleep, and enhance overall quality of life for people with erosive reflux disease.
How similar studies have performed: Other potassium-competitive acid blockers such as vonoprazan have shown promising acid suppression and symptom relief compared with proton pump inhibitors, but direct clinical data for zastaprazan remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ansan and 9 other locations
- 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)
Study contacts
- Study coordinator: Byung-Wook Kim
- Email: gastro@catholic.ac.kr
- Phone: +82-1544-9004
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.