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NCT07875933
Efficacy and Safety of JP-1366-based Triple Therapy in Helicobacter Pylori-positive Subjects
Conditions: H. Pylori Eradication Therapy
Sex: All
Ages: 19 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 414
Sponsor: Onconic Therapeutics Inc.
Summary
This study aims to evaluate the Efficacy and Safety of JP-1366-based Triple-Therapy in H. pylori-positive Subjects
Eligibility Criteria
Inclusion Criteria:
1. Adult males or females aged ≥19 years and ≤75 years at the time of written informed consent
2. Participants with a confirmed positive result for 13C-UBT performed at the Screening Visit (Visit 1)
3. Participants with a confirmed positive result for H. pylori in the CLO test performed at the Screening Visit (Visit 1) (If test results obtained at the same study site within 12 weeks prior to the Screening Visit (Visit 1) are available, those results may be used.)
Exclusion Criteria:
1. Participants diagnosed with significant acute upper gastrointestinal bleeding within 4 weeks prior to the Screening Visit (Visit 1)
2. Participants with a procedural history that affects gastric acid secretion (partial gastrectomy, vagotomy, etc.) prior to the Screening Visit (Visit 1)
3. Participants with Zollinger-Ellison syndrome or other hyperchlorhydria disorders at the Screening Visit (Visit 1)
4. Participants who have had H. pylori eradication therapy at least once before the Screening Visit (Visit 1)
Source: ClinicalTrials.gov (NCT07875933). StuddyBuddy aggregates publicly available trial information.