A Phase 4 interventional study of Clarithromycin 500 mg and Amoxicillin 1 g in H Pylori, sponsored by Rehman Medical Institute - RMI. Not yet recruiting at 1 site in Pakistan. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by Rehman Medical Institute - RMI · Phase 4, Interventional, and Treatment
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.
Currently, there are numerous H. pylori eradication regimens, but opinions vary regarding the effectiveness of those based on P-CAB or PPI. Zhang et al. 4 concluded that the P-CAB-based triple regimen was superior to the PPI-based regimen, whereas Du et al.5 suggested that a vonoprazan and amoxicillin duo regimen may be the preferred first-line option for H. pylori eradication in clinical practice. However, due to limited evidence, the efficacy of various H. pylori eradication regimens using tegoprazan or vonoprazan could not be compared.
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.
Objective: To compare the efficacy of vonoprazan-based H. pylori eradication therapy with conventional proton pump inhibitors based therapy.
Rehman Medical Institute - RMI is the lead sponsor of 24 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Clarithromycin 500 mg · Drug: Amoxicillin 1 g · Drug: Omeprazole 40 mg
Drug: Clarithromycin 500 mg · Drug: Amoxicillin 1 g · Drug: Vonoprazan 20 mg
Drug: Levofloxacin 500 mg · Drug: Amoxicillin 1 g · Drug: Omeprazole 40 mg
Participants receiving second-line therapy (levofloxacin + amoxicillin) with vonoprazan as the acid suppressant.
Drug: Levofloxacin 500 mg · Drug: Amoxicillin 1 g · Drug: Vonoprazan 20 mg
Clarithromycin 500 mg orally twice daily for 14 days
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
Clarithromycin 500 mg orally twice daily for 14 days
Amoxicillin 1 g orally twice daily for 14 days
Vonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks
Levofloxacin 500 mg orally once daily for 14 days
Amoxicillin 1 g orally twice daily for 14 days
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
Levofloxacin 500 mg orally once daily for 14 days
Amoxicillin 1 g orally twice daily for 14 days
Vonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks
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
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
Plan to share: Yes
Supporting information: Study protocol
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Clarithromycin · Omeprazole · Vonoprazan · Levofloxacin
Rehman Medical Institute - RMI