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NCT Number: NCT07268820

Heartburn, Gastroesophageal Reflux Disease

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).

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University Ansan Hospital, Ansan, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Zastaprazan

Drug

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

Other names: P-CAB

Esomeprazole

Drug

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

Other names: PPI

Primary outcomes

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

    Time frame: Week 2

    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.

Secondary outcomes

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

    Time frame: Week 4

    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.

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

    Time frame: Baseline, Week 2, Week 4

    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.

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

    Time frame: Baseline, Week 2, Week 4

    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.

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

    Time frame: Baseline, Week 2, Week 4

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Byung-Wook Kim

CONTACT

[email protected]

+82-1544-9004

Sponsors and collaborators

Lead sponsor

Incheon St.Mary's Hospital

Other

Registry information

Official study title

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

Acronym: GERD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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