Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 in Patients With Non-erosive Gastroesoph… (NCT07160790) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 in Patients With Non-erosive Gastroesophageal Reflux Disease
321 participantsStarted 2025-09-02
Plain-language summary
This study aims to evaluate the efficacy and safety of JP-1366 in Patients with NERD
Who can participate
Age range19 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects who have experienced both heartburn and acid regurgitation
* Subjects in whom no mucosal breaks were observed on upper GI endoscopy at Visit 1 by LA Classification
* Subjects who fully understand this clinical trial and voluntarily signed the informed consent form
Exclusion Criteria:
* Subjects who have significant gastrointestinal diseases or procedures affecting the esophagus, stomach, or duodenum
* Subjects who have a history of recent substance abuse, malignancy, systemic autoimmune or immune deficiency diseases, refractory response to PPI/P-CAB, hypersensitivity to study drugs, genetic metabolic disorders, or significant psychiatric conditions.
* Subjects who showed clinically significant abnormalities in laboratory tests
* Positive result in the H. pylori test
* Pregnant or breast-feeding women
* Subjects who require hospitalization are scheduled to undergo surgery during the study period, or have undergone major surgery requiring general anesthesia
* Other people deemed unsuitable for participation in this study according to the medical opinion of the investigator
What they're measuring
1
The proportion of days with no heartburn
Timeframe: The proportion of days with no heartburn for 24 hours (daytime/nighttime) over 4 weeks