RCT comparing VA-VMS sequential and VAM HP eradication for Early age patients

Phase 2

• Conditions: Helicobacter pylori infection; Helicobacter pylori

• Registration Number: JPRN-jRCTs031180209
• Lead Sponsor: Sue Soichiro

Brief Summary

This study showed potential of 14-day sequential therapy containing vonoprazan and amoxicillin for 7 days followed by vonoprazan, metronidazole and sitafloxacin for 7 days and 7-day triple therapy with vonoprazan, amoxicillin and metronidazole. There was no problem in safety.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-07
• Study Completion: 2022-03-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

(1) A patient with Helicobacter pylori infection.
(2) A patient who can perform stool antigen test of Helicobacter pylori after 8 weeks from treatment completion.
(3)A patient who give a written informed consent.

Exclusion Criteria

(1) A patient with history of Helicobacter pylori eradication.
(2) Pregnancy.
(3) Lactation.
(4) Patients allergic to penicillin.
(5) Past history of allergy for the drugs used in this study.
(6) A patient with brain and spinal cord disease.
(7) A patient with infectious mononucleosis.
(8) Severe liver dysfunction, serere renal dysfunction, severe heart dysfunction.
(9) Patient who is disualified 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