Interventional Recruiting Phase 4
NCT05191888 on ClinicalTrials.gov
14-day PCAB-based High-dose Dual Therapy and14-day PCAB-based Triple Therapy vs 14-day PPI-based Reverse Hybrid Therapy
Official title: 14-day PCAB-based and Reverse Hybrid Therapy Fro Helicobacter Pylori
- Sponsor: Kaohsiung Medical University
- Enrollment: 906 (Estimated)
- Study start: 2021-08-06 (Actual)
- Primary completion: 2024-12-31 (Estimated)
- Study completion: 2024-12-31 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- InterventionModelDescription: 1. 14-day vonoprazan high-dose two-in-one therapy 2. 14-day vonoprazan triple therapy 3. 14th Rabeprazole reverse mixed therapy
- Masking: None
- PrimaryPurpose: Treatment
Brief Summary
1. Test for Helicobacter pylori. The test items include urease test, histology, bacterial culture, serology, and urea breath test. At least two positive results can be used to confirm the diagnosis.
2. To ensure that the research results are not artificially distorted, this trial is a randomized study. Random allocation (which means that the subjects will use the "random number table generated by a computer similar to the lottery" to determine the treatment group) accept one of the following schemes (1:1:1).
Conditions
- Helicobacter Pylori Eradication
Intervention / Treatment
- Drug: Vonoprazan and Amoxicillin
- Drug: Vonoprazan, Amoxicillin and Clarithromycin
- Drug: Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole
Primary Outcome Measures
-
the rate of Helicobacter pylori
(6 week after finishing study drugs)
Evaluate eradication outcome by 13C uear breath test
Countries
Taiwan
Locations and Investigators
-
Kaohsiung Medical University Hospital, Kaohsiung, Taiwan (Recruiting)
- Deng-Chyang Wu, MD,PHD