RCT of Vonoprazan and high dose Amoxicillin eradication

JRCT ID: jRCTs031200128

Registered date:23/09/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Helicobacter pylori infection
• Date of first enrollment: 04/11/2020
• Target sample size: 120
• Study type: Interventional

Intervention(s)

(1)Dual therapy
Vonoprazan (20mg) given on twice daily and
Amoxicillin (500mg) given on hour times daily
For 7 days
(2)Triple therapy
Vonoprazan (20mg), amoxicillin (500mg), and clarithromycin (400mg) given on twice daily for 7days

Outcome(s)

• Primary Outcome: Eradication rate (PPS)

Secondary Outcome

(1) Eradication rate (PPS)
(2) Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients infected with Helicobacter pylori. Positive patients by Urea breath test, stool Helicobacter pylori antigen test, Helicobacter pylori culture, anti-Helicobacter pylori antibody test (blood), rapid urease test (biopsy sample), or histological diagnosis (biopsy sample) are treat with infected. Patients who give a written informed consent.
• Exclude criteria: Patients who have Helicobacter pylori eradication history. Pregnancy or lactation. Past history of allergy for the drugs used in this therapy. Patients with infectious mononucleosis. Patients using atazanavir, rilpivirine, pimozide, ergotamine, suvorexant, lomitapide mesylate, tadalafil, ticagrelor, ibrutinib, asuna previr, ivavradine, venetoclax, lurasidone hydrochloride, anamorelin hydrochloride, finerenone, or isavuconazonium sulfate. Patients using colchicine with liver dysfunction or renal dysfunction. Severe liver dysfunction, severe renal dysfunction, severe heart dysfunction. Patients who are disqualified for the study by phyusicians.

Related Information

• Primary Sponsor: Sue Soichiro
• Source(s) of Monetary Support: Yokohama City University