Comparing Tegoprazan and Lansoprazole for treating H. pylori infections
A Randomized, Double-Blind, Active-controlled, Multi-center, Therapeutic Exploratory Study to Evaluate the Safety and Efficacy of a Standard Triple Therapy With Tegoprazan (by Dose) in H. Pylori Positive Patients
This study is testing whether a new medication called Tegoprazan works better than Lansoprazole in treating H. pylori infections in patients.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 381 (estimated) |
| Ages | 19 Years to 75 Years |
| Sex | All |
| Sponsor | HK inno.N Corporation Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05933031 on ClinicalTrials.gov |
What this trial studies
This exploratory study aims to evaluate the safety and efficacy of Tegoprazan in a dose-specific standard triple therapy compared to Lansoprazole standard triple therapy in patients who are positive for H. pylori. The study is designed as a randomized, double-blind, active-controlled, multicenter trial, where participants will receive treatment twice a day for 14 days. The goal is to determine which therapy is more effective in eradicating the H. pylori infection.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who are H. pylori positive and have upper gastrointestinal disease.
Not a fit: Patients who have previously received therapy for H. pylori eradication or have used certain medications within specified timeframes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from H. pylori infections.
How similar studies have performed: While this approach is exploratory, previous studies have shown varying success with different therapies for H. pylori, making this a potentially valuable investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * H. pylori positive at screening * Subjects who have upper gastrointestinal disease Exclusion Criteria: * Having received prior therapy for eradication of H. pylori * Prior use of P-CAB, proton pump inhibitors (PPIs), H2 receptor blockers within 14 days * Prior use of H. pylori eradication effective antibiotics, bismuth within 28 days
Where this trial is running
Seoul
- Chung-Ang University Hosptial — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Jae Gyu Kim — Chung-Ang University Hosptial, Chung-Ang University College of Medicine
- Study coordinator: Eun Ji Kim
- Email: eunji.kim24@inno-n.com
- Phone: 82-2-6477-0290
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.