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

NCT ID: NCT07160790

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

321 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-02

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-erosive Gastroesophageal Reflux Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1: JP-1366 A mg + Placebo

Group Type EXPERIMENTAL

JP-1366 + placebo

Intervention Type DRUG

taking JP-1366 + placebo

Group 2: JP-1366 B mg + Placebo

Group Type EXPERIMENTAL

JP-1366 + placebo

Intervention Type DRUG

taking JP-1366 + placebo

Placebo + Placebo

Group Type PLACEBO_COMPARATOR

Placebo + Placebo

Intervention Type DRUG

taking placebo + placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

JP-1366 + placebo

taking JP-1366 + placebo

Intervention Type DRUG

Placebo + Placebo

taking placebo + placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Onconic Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JP-1366-305

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.