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NCT02827942

Comparison of Vonoprazan-based Dual and Triple Therapies for H. Pylori Eradication

Completed Phase 3 Last updated 9 April 2019
What this trial tests

Phase 3 trial testing vonoprazan 20 mg bid in Gastritis Associated With Helicobacter Pylori in 112 participants. Completed in 31 March 2019.

Timeline
1 July 2016
Primary endpoint
31 December 2018
31 March 2019

Quick facts

Lead sponsorHamamatsu University
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment112
Start date1 July 2016
Primary completion31 December 2018
Estimated completion31 March 2019
Sites1 location across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Hamamatsu University

Who can join

Adults 20 to 90, any sex, with Gastritis Associated With Helicobacter Pylori. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients infected with H. pylori were randomly assigned to the dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week or the triple therapy with vonoprazan 20 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg or metronidazole 250 mg bid bid for 1 week. Success or failure of eradication was determined by the 13C-urea breath test performed at 1 month after the therapy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Clinical Implications of Proton Pump Inhibitors and Vonoprazan Micro/Nano Drug Delivery Systems for Gastric Acid-Related Disorders and Imaging.
    Setia A, Challa RR, Vallamkonda B, Vaishali, et al · · 2024 · cited 3× · PMID 39507107 · DOI 10.7150/ntno.100727

Verify or expand the search:

Other recruiting trials for Gastritis Associated With Helicobacter Pylori

Currently open trials in the same condition.

Other Hamamatsu University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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