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Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection

NCT04167670 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1046

Last updated 2022-04-05

Study results available
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Summary

To compare the efficacy of Helicobacter pylori (HP) eradication with vonoprazan dual and triple therapy regimens versus lansoprazole triple therapy regimen in participants with HP infection, excluding participants who had a clarithromycin or amoxicillin resistant strain of HP at baseline.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Vonoprazan

Over-encapsulated tablets administered orally.

DRUG

Amoxicillin

Capsules administered orally.

DRUG

Clarithromycin

Tablets administered orally.

DRUG

Lansoprazole

Over-encapsulated capsules administered orally.

Sponsors & Collaborators

  • Phathom Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Phathom Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-10
Primary Completion
2021-03-10
Completion
2021-03-18
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Hungary
  • Poland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04167670 on ClinicalTrials.gov