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A Randomized Controlled Trial Comparing 7 day Vonoprazan based Triple Therapy and 14 day Omeprazole based Triple Therapy for Helicobacter pylori Infection

A Randomized Controlled Trial Comparing 7 day Vonoprazan based Triple Therapy and 14 day Omeprazole based Triple Therapy for Helicobacter pylori Infection

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210219007
Enrollment
120
Registered
2021-02-19
Start date
2019-11-01
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

Helicobacter pylori infection Helicobacter pylori infection

Interventions

Vonoprazan 20mg bid , amoxicillin 1000mg bid, clarithromycin 500 mg bid for 7 day,Omeprazole 20mg bid, amoxicillin 1000mg bid, clarithromycin 500 mg bid for 14 day
Active Comparator Drug,Placebo Comparator Drug

Sponsors

Research department, Rajavithi hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Present with Helicobacter pylori infection: confirm by one or more of the following methods -Urea breath test -Rapid urea test or - Histology 2. Patient agree to joint the project

Exclusion criteria

Exclusion criteria: 1.history of allergy to PPI, vonoprazan, penicillin , clarithromycin 2. Previous H. Pylori eradication therapy 3. History of antibiotic to effect H. Pylori treatment before 1 month 4. History of GI malignancy or surgery 5. Serious cardiovascular, pulmonary, renal, hepatic disorder or malignancy 6. Pregnancy or lactating 7. History of drug or alcohol abuse

Design outcomes

Primary

MeasureTime frame
Eradication rate of H. Pylori infection 4-6 week Eradication success was evaluated by 14C-urea breath test at 4-6 weeks after the completion of treatment

Secondary

MeasureTime frame
Adverse event of H. Pylori treatment 3 and 14 days adverse reactions listed in the questionnaires were bitter taste, nausea and vomiting, diarrhea, and fatigue

Countries

Thailand

Contacts

Public ContactRajavithi hospital Rajavithi hospital

Rajavithi hospital

Research.Rajavithihospital@gmail.com023548108

Outcome results

None listed

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