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Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis

NCT04124926 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1027

Last updated 2022-07-29

Study results available
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Summary

To evaluate the efficacy and safety of vonoprazan compared to lansoprazole in participants with erosive esophagitis.

Conditions

  • Erosive Esophagitis

Interventions

DRUG

Vonoprazan

Over-encapsulated tablet administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.

DRUG

Lansoprazole

Over-encapsulated capsule administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.

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
2019-10-28
Primary Completion
2021-07-29
Completion
2021-08-24
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 NCT04124926 on ClinicalTrials.gov