Heartburn, Gastroesophageal Reflux Disease
ConditionGERD
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorIncheon St.Mary's Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Zastaprazan
DrugParticipants in this arm will receive zastaprazan. This group serves as the experimental treatment group exploratorily evaluating drug for GERD.
Esomeprazole
DrugParticipants in this arm will receive esomeprazole. This group serves as the active comparator treatment group exploratorily evaluating drug for GERD.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: ZastaprazanExperimental treatment 1 intervention
Group B: EsomeprazoleActive comparator 1 intervention
Trial outcomes
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.
Time frame
Week 2Secondary 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.
Time frame
Week 42
Mean change from baseline in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score
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.
Time frame
Baseline, Week 2, Week 43
Mean change from baseline in Gastrointestinal Symptom Rating Scale (GSRS) score
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.
Time frame
Baseline, Week 2, Week 44
Change from baseline in Gastroesophageal Reflux Disease Questionnaire (GerdQ) score
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.
Time frame
Baseline, Week 2, Week 4Sponsors and contacts
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Source ClinicalTrials.gov