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

NCT07160790 | Not Yet Recruiting Phase 3

• 1 other identifier: JP-1366-305
• Study Type: interventional
• Target: 321
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Non-erosive Gastroesophageal Reflux Disease

Keywords

Non-erosive Reflux Disease; Non-Erosive Gastro-Esophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• The proportion of days with no heartburn

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

Study Arms (3)

Group 1: JP-1366 A mg + Placebo

EXPERIMENTAL

Drug: JP-1366 + placebo

Group 2: JP-1366 B mg + Placebo

EXPERIMENTAL

Drug: JP-1366 + placebo

Placebo + Placebo

PLACEBO COMPARATOR

Drug: Placebo + Placebo

Interventions

JP-1366 + placebo DRUG

taking JP-1366 + placebo

Group 1: JP-1366 A mg + Placebo; Group 2: JP-1366 B mg + Placebo

Placebo + Placebo DRUG

taking placebo + placebo

Placebo + Placebo

Eligibility Criteria

• Age: 19 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Onconic Therapeutics Inc.: lead

MeSH Terms

Conditions

Non-Erosive Reflux Disease

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share