Comparison of Omeprazole vs Vonoprazon in Treatment of H Pylori Infection

ConditionH Pylori

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age12+

SponsorRehman Medical Institute - RMI

About this trial

Current studies have primarily focused on comparing the advantages and disadvantages of P-CAB and PPI drugs, with little comparison between different P-CAB drugs or between regimens with varying drug combinations and treatment durations.

This study aims to evaluate the clinical effectiveness of vonoprazan-based H. pylori eradication therapy and compare it to that of conventional PPI based therapy in clinical practice.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

All patients who tested positive on stool antigen

Disqualifiers

patients under 12 years old.

Patients who have penicillin allergy.

Patients who have underlying dysrhythmia forbidding the use of macrolide -. Patient who have hypersensitivity to any of these antibiotics or proton pump inhibitors.

Trial design

Design model

Parallel

Treatments tested in this trial

Clarithromycin 500 mg
Drug
Clarithromycin 500 mg orally twice daily for 14 days
Amoxicillin 1 g
Drug
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
Omeprazole 40 mg
Drug
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
Clarithromycin 500 mg
Drug
Clarithromycin 500 mg orally twice daily for 14 days
Amoxicillin 1 g
Drug
Amoxicillin 1 g orally twice daily for 14 days
Vonoprazan 20 mg
Drug
Vonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks
Levofloxacin 500 mg
Drug
Levofloxacin 500 mg orally once daily for 14 days
Amoxicillin 1 g
Drug
Amoxicillin 1 g orally twice daily for 14 days
Omeprazole 40 mg
Drug
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
Levofloxacin 500 mg
Drug
Levofloxacin 500 mg orally once daily for 14 days
Amoxicillin 1 g
Drug
Amoxicillin 1 g orally twice daily for 14 days
Vonoprazan 20 mg
Drug
Vonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks

Treatment groups

128 Participants

are divided into 4 treatment groups

Group A: First-Line Therapy with OmeprazoleExperimental treatment 3 interventions

Group B: First-Line Therapy with VonoprazanExperimental treatment 3 interventions

Group C: Second-Line Therapy with OmeprazoleExperimental treatment 3 interventions

Group D: Second-Line Therapy with VonoprazanExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

H. pylori Eradication Rate

Proportion of participants with successful eradication of Helicobacter pylori infection, confirmed by a negative stool antigen test.

Time frame

4-6 weeks after completion of therapy

Secondary outcomes

Incidence of Adverse Events

Number and type of treatment-related adverse effects (e.g., nausea, diarrhea, headache, abdominal discomfort) reported by participants during or after therapy

Time frame

During the 6-week treatment and follow-up period

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rehman Medical Institute - RMI

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: