Clinical trial
Seven-Day Vonoprazan-Based Triple Therapy With High-Dose Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy: A Randomized Controlled Trial in Taiwan
Name
FJUH110108
Description
This study aims to compare the efficacy of the current standard first-line anti-helicobacter pylori regimen, extended proton pump inhibitor-based sequential therapy, with that of vonoprazan-based triple therapy, through a randomized controlled trial.
Trial arms
Trial start
2021-12-01
Estimated PCD
2023-12-30
Trial end
2024-02-28
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Vonoprazan-based triple therapy
vonoprazan 20mg+amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days
Arms:
Vonoprazan-based triple therapy group
Other names:
VAC-7
Extended sequential therapy
Lansoprazole 30mg + amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg twice daily for 7 days
Arms:
Extended sequential therapy group
Other names:
S-14
Size
628
Primary endpoint
Eradication rate of helicobacter pylori
Assessed at least 6 weeks after the therapy
Eligibility criteria
Inclusion Criteria:
* Patients with H.pylori infection who was over 20 years old and agree to participate in the trial will be recruited.
Exclusion Criteria:
* Who had received helicobacter pylori eradication before
* Who are known to be allergic to any drug used in this trial
* Pregnant women
* Who are refuse to participate in the trial for any reason
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 628, 'type': 'ACTUAL'}}
Updated at
2023-08-07
1 organization
2 products
1 indication
Organization
Fu Jen Catholic University HospitalIndication
Helicobacter pyloriProduct
Extended sequential therapy