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Comparison of Vonoprazan to Esomeprazole in Participants With Symptomatic GERD Who Responded Partially to a High Dose of Proton Pump Inhibitor (PPI)

NCT02743949 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2020-02-18

Study results available
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Summary

The purpose of this study is to determine the effect of vonoprazan compared to esomeprazole for preventing heartburn symptoms over a 4-week treatment period in participants who have a partial response to treatment with esomeprazole.

Conditions

  • Gastroesophageal Reflux

Interventions

DRUG

Vonoprazan

Vonoprazan over-encapsulated capsules

DRUG

Esomeprazole

Esomeprazole over-encapsulated tablets

DRUG

Esomeprazole Placebo

Esomeprazole placebo-matching capsules

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-14
Primary Completion
2018-10-05
Completion
2018-10-12

Countries

  • Belgium
  • Bulgaria
  • Czechia
  • Estonia
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT02743949 on ClinicalTrials.gov