Nighttime heartburn treatment for people with erosive reflux disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Byung-Wook Kim
• Email: gastro@catholic.ac.kr
• Phone: +82-1544-9004

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.