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A Randomized controlled trial of clarithromycin 800 mg versus 400 mg as part of first-line triple therapy with vonoprazan for Helicobacter pylori gastritis

A RANDOMIZED TRIAL OF CLARITHROMYCIN 800 mg VERSUS 400 mg AS PART OF FIRST-LINE TRIPLE THERAPY - A RANDOMIZED TRIAL OF CLARITHROMYCIN 800 mg VERSUS 400 mg AS PART OF FIRST-LINE TRIPLE THERAPY

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045798
Enrollment
516
Registered
2021-10-21
Start date
2017-05-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori gastritis

Interventions

Vonoprazan (VPZ) 20mg, Amoxicillin (ABPC) 750mg, Clarithromycin (CAM) 200mg, for the first 7days, with all drugs given twice daily VPZ 20mg, ABPC 750mg, CAM 400mg, for the first 7days, with all drugs

Sponsors

Takamatsu Red Cross Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who received a diagnosis of Helicobacter pylori gastritis by any one method of a rapid urease test, a urea breath test, a blood antibody test, a stool antigen test, and microbial culture.

Exclusion criteria

Exclusion criteria: 1. Patients who have histories of eradication therapy for Helicobacter pylori. 2. Patients who received any one of lansoprazole, esomeprazole, omeprazole, and vonoprazan within 2 weeks. 3. Patients who suggested or received a diagnosis of other infectious diseases. 4. Patients being treated for acute gastritis, advanced gastric cancer, and gastric MALT lymphoma. 5. Patients after gastrectomy. 6. Patients who have coexisting severe heart disease, liver disease, respiratory disease, metabolic disease, neuromuscular disease, and severe chronic renal failure (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2). 7. Patients who have a past history of allergy for vonoprazan, esomeprazole, amoxicillin, and clarithromycin. 8. Pregnancy or lactating women. 9. Patients requiring hospitalization..

Design outcomes

Primary

MeasureTime frame
Eradication rate of the first-line therapy assessed by a urea breath test from 8 to 12 weeks after cessation of therapy.

Secondary

MeasureTime frame
Effects of clarithromycin resistance, eGFR, alcohol consumption, and smoking on the eradication rate of each group, and the incidence and severity of adverse events

Countries

Japan

Contacts

Public ContactHiroyuki Tamaki

Takamatsu Red Cross Hospital Department of gastroenterology

h-tama@gc4.so-net.ne.jp0878317101

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026