Evaluation of the Efficacy and Safety of Vonoprazan in Patients with Nonerosive Gastroesophageal Reflux Disease: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study.

ABSTRACT:

Background

For many patients, current treatments do not adequately resolve heartburn in nonerosive reflux disease (NERD).

Objective

To compare vonoprazan and placebo with respect to the frequency and severity of heartburn in patients with NERD.

Methods

This Phase III, double-blind, placebo-controlled, parallel-group, multicenter study included patients in Japan aged ≥20 years with Grade N or M NERD and recurrent acid reflux symptoms. Patients were blinded and randomized 1:1:1 to receive placebo or vonoprazan 10 mg or 20 mg. The primary efficacy outcome was the proportion of days without heartburn measured by patient scores during the 4-week treatment period.

Results

Eight hundred twenty-seven patients were randomized (placebo: n = 278, vonoprazan 10 mg: n = 278

SUBMITTER: Kinoshita Y 

PROVIDER: S-EPMC5238607 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature