Status:
NOT_YET_RECRUITING
Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 in Patients With Non-erosive Gastroesophageal Reflux Disease
Lead Sponsor:
Onconic Therapeutics Inc.
Conditions:
Non-erosive Gastroesophageal Reflux Disease
Eligibility:
All Genders
19-75 years
Phase:
PHASE3
Brief Summary
This study aims to evaluate the efficacy and safety of JP-1366 in Patients with NERD
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT07160790
Start Date
September 2 2025
End Date
June 30 2026
Last Update
September 8 2025
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