Heartburn, Gastroesophageal Reflux Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zastaprazan, Esomeprazole.
- Who it may be relevant to
- Registry conditions: GERD. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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).
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.
Interventions
- Drug Zastaprazan
Participants in this arm will receive zastaprazan. This group serves as the experimental treatment group exploratorily evaluating drug for GERD. - Drug Esomeprazole
Participants in this arm will receive esomeprazole. This group serves as the active comparator treatment group exploratorily evaluating drug for GERD.
Primary outcome measures
- Proportion of participants without sleep disturbance related to nighttime heartburn during the last 7 days [Time frame: Week 2]
Secondary outcome measures (4)
- Proportion of participants without sleep disturbance related to nighttime heartburn during the last 7 days [Time frame: Week 4]
- Mean change from baseline in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score [Time frame: Baseline, Week 2, Week 4]
- Mean change from baseline in Gastrointestinal Symptom Rating Scale (GSRS) score [Time frame: Baseline, Week 2, Week 4]
- Change from baseline in Gastroesophageal Reflux Disease Questionnaire (GerdQ) score [Time frame: Baseline, Week 2, Week 4]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
South Korea · 10 centers
- Korea University Ansan Hospital — Ansan
- Pusan National University Hospital — Busan
- Kyungpook National University Chilgok Hospital — Chilgok
- Hallym University Chuncheon Sacred Heart Hospital — Chuncheon
- Chonnam National University Hospital — Gwangju
- Catholic University of Korea, Incheon ST. Mary's Hospital — Incheon
- Gangnam Severance Hospital — Seoul
- Kyung Hee University Hospital — Seoul
- … and 2 more centers
Identifiers
NCT: NCT07268820 · JL-JAQ-402