Non-erosive Gastroesophageal Reflux Disease
Conditions
Keywords
Non-erosive Reflux Disease, Non-Erosive Gastro-Esophageal Reflux Disease
Brief summary
This study aims to evaluate the efficacy and safety of JP-1366 in Patients with NERD
Interventions
DRUGJP-1366 + placebo
taking JP-1366 + placebo
taking placebo + placebo
Sponsors
Onconic Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of days with no heartburn | The proportion of days with no heartburn for 24 hours (daytime/nighttime) over 4 weeks |
Outcome results
None listed