Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 in Patients With Non-erosive Gastroesophageal Reflux Disease

Onconic Therapeutics

Status and phase

Not yet enrolling

Phase 3

Conditions

Non-erosive Gastroesophageal Reflux Disease

Treatments

Drug: Placebo + Placebo

Drug: JP-1366 + placebo

Study type

Interventional

Funder types

Industry

Identifiers

JP-1366-305

Details and patient eligibility

About

This study aims to evaluate the efficacy and safety of JP-1366 in Patients with NERD

Enrollment

321 estimated patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

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