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

August 29, 2025 updated by: Onconic Therapeutics Inc.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

321

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo + Placebo
Drug: Placebo + Placebo
taking placebo + placebo
Experimental: Group 1: JP-1366 A mg + Placebo
Drug: JP-1366 + placebo
taking JP-1366 + placebo
Experimental: Group 2: JP-1366 B mg + Placebo
Drug: JP-1366 + placebo
taking JP-1366 + placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Onconic Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 2, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

August 29, 2025

First Submitted That Met QC Criteria

August 29, 2025

First Posted (Estimated)

September 8, 2025

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JP-1366-305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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