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NCT Number: NCT07160790

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

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

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Key information

Conditions

Non-erosive Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Non-Erosive Reflux Disease

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JP-1366 + placebo

Drug

taking JP-1366 + placebo

Placebo + Placebo

Drug

taking placebo + placebo

Primary outcomes

  1. The proportion of days with no heartburn

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

Sponsors and collaborators

Lead sponsor

Onconic Therapeutics Inc.

Industry

Registry information

Official study title

Efficacy and Safety of JP-1366 in Patients With Non-erosive Gastroesophageal Reflux(NERD) Disease: Double-blind, Randomized

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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