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

Not Applicable

Not yet recruiting

• Conditions: Non-erosive Gastroesophageal Reflux Disease
• Interventions: Drug: JP-1366 + placebo; Drug: Placebo + Placebo

• Registration Number: NCT07160790
• Lead Sponsor: Onconic Therapeutics Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-29
• Study First Submitted QC: 2025-08-29
• Last Update Submitted: 2025-08-29
• Study Start: 2025-09-02
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 321

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: JP-1366 A mg + Placebo	JP-1366 + placebo	-
Group 2: JP-1366 B mg + Placebo	JP-1366 + placebo	-
Placebo + Placebo	Placebo + Placebo	-

Primary Outcome Measures

Name	Time	Method
The proportion of days with no heartburn	The proportion of days with no heartburn for 24 hours (daytime/nighttime) over 4 weeks