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Ineffectiveness of 14-day Vonoprazan-based dual therapy and Vonoprazan-based triple therapy for Helicobacter pylori Eradication in area of high Clarithromycin resistance: A prospective randomized study

Ineffectiveness of 14-day Vonoprazan-based dual therapy and Vonoprazan-based triple therapy for Helicobacter pylori Eradication in area of high Clarithromycin resistance: A prospective randomized study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20191219003
Enrollment
Unknown
Registered
2019-12-19
Start date
2019-11-29
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N/A Helicobacter Pylori Infection

Interventions

day dual therapy containing 500 mg amoxicillin 4 times daily and 20 mg vonoprazan twice daily ,14&#45
day triple therapy containing 1 g amoxicillin twice daily&#44
1 g clarithromycin MR once daily&#44
and 20 mg vonoprazan twice daily
Active Comparator Drug,Active Comparator Drug
vonoprazan&#45
based dual therapy,vonoprazan&#45
based triple therapy

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Thai patients with the age between 18 and 75 years Detecting for H.pylori infection with positive urease test and/or pathological findings of H.pylori and/or positive

Exclusion criteria

Exclusion criteria: Any cases with upper gastrointestinal bleeding Being treated with medications affecting the research outcome&#44; for example&#44; by using antibiotics including amoxicillin&#44; clarithromycin&#44; metronidazole or fluoroquinolone within 1 month before the enrollment. Contraindicated for gastric biopsy such as coagulopathy. Any history of drug allergy for amoxicillin&#44; clarithromycin or vonoprazan. Receiving proton pump inhibitor within 4 weeks or receiving any antibiotics or bismuth within 2 weeks. Being pregnant or raising children with lactation. Having history of H.pylori eradication treatment. Having severe underlying disease including end&#45;stage renal disease requiring hemodialysis or peritoneal dialysis (GFR < 15)&#44; cirrhosis with Child&#45;Pugh classification grade C&#44; immunocompromised host with AIDS&#44; malignancy and/or bed ridden cerebrovascular disease. Any cases who receiving anticoagulant. Having previous gastric surgery. Unwilling to participate into research. Having history of taking previous medications which interacted with the research treatment. Having underlying heart disease including congenital long QT syndrome.

Design outcomes

Primary

MeasureTime frame
eradication rate of Helicobacter pylori infection 4 weeks after last dose eradication rate of 14&#45;day vonoprazan&#45;based dual therapy and 14&#45;day vonoprazan&#45;based triple therapy

Secondary

MeasureTime frame
Adverse effect ุุ6 month To measure the adverse effect reaction of 14&#45;day vonoprazan&#45;based dual therapy and 14&#45;day vonoprazan

Countries

Thailand

Contacts

Public ContactLikhasit Sanglutong

Thammasat University Hospital

lickhasit1986@gmail.com084-911-5775

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026