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

JRCT ID: jRCTs031180209

Registered date:07/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Helicobacter pylori infection
• Date of first enrollment: 22/01/2019
• Target sample size: 190
• Study type: Interventional

Intervention(s)

A 14-day sequential therapy containing vonoprazan and amoxicillin for 7 days followed by vonoprazan, metronidazole and sitafloxacin for 7 days
: Vonoprazan 20mg bid Amoxicillin 750mg bid 7 days followed by Vonoprazan 20mg bid Metronidazole 250mg bid Sitafloxacin 100mg bid 7 days (Total 14 days)

A 7-day triple therapy with vonoprazan, amoxicillin and metronidazole
: Vonoprazan 20mg bid Amoxicillin 750mg bid Metronidazole 250mg bid 7 days

Outcome(s)

• Primary Outcome: Eradication rate
• Secondary Outcome: Adverse event by questionnaire

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 40age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Sue Soichiro
• Source(s) of Monetary Support: Yokohama City University,Yokohama Foundation for Advancement of medical Science
• Secondary ID(s): UMIN000032109