PCAB-based H.pylori eradication study for patients with penicillin allergy (CAP-pen study)
Phase 2
- Conditions
- Helicobacter pylori infectionHelicobacter pylori
- Registration Number
- JPRN-jRCTs031180133
- Lead Sponsor
- Sue Soichiro
- Brief Summary
First line 7-days therapy with vonoprazan, clarithromycin and metronidazole, and second line 7-days therapy with vonoprazan, metronidazole and sitafloxacin showed sufficient efficacy and safety for Helicobacter pylori infected patients with penicillin allergy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Penicillin allergic patients with H.pylori infection who want to take eradication treatment. Patients who give a written informed consent.
Exclusion Criteria
Past history of taking second line H.pylori eradication therapy. Pregnancy or lactation. Past history of allergy for the drugs used in this therapy. Severe liver dysfunction, Severe renal dysfunction, Severe heart dysfunction. Patients who are disqualified for the study by physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Eradication rate
- Secondary Outcome Measures
Name Time Method Adverse event by questionnaire