Heartburn study, for people with non-erosive gastroesophageal reflux disease

  • STATUS
    Recruiting
  • sponsor
    Phantom Pharmaceuticals
Updated on 8 August 2022
reflux

Summary

A research study to evaluate the efficacy and safety of vonoprazan 10 mg, 20 mg, and 40 mg compared to placebo for relief of episodic heartburn in subjects with symptomatic non-erosive gastroesophageal reflux disease

Description

NERD is a disease that causes occasional heartburn (called “episodic heartburn”), a burning sensation in your chest and throat without erosions or wearing away of the inner lining of the esophagus. The standard treatment for NERD is currently the use of a class of medication called proton pump inhibitors (PPI). The purpose of this study, which involves research, is to determine whether the investigational drug, vonoprazan, is safe and effective in the potential treatment of this disease compared to a placebo. The placebo looks like the investigational drug, vonoprazan, but does not contain any active substance.
 
Study Duration: The total duration of the study is up to 33 weeks. The Screening Period is up to 5 weeks, Placebo-controlled Treatment Period is 4 weeks, Extension Period is 20 weeks, and safety follow-up is 4 weeks after last study drug administration
 
Study Procedures: Include physical exams with the study doctors, laboratory assessments/blood draws, EGD, pregnancy tests, ECGs, and symptom tracking with an electronic diary.

Details
Condition Heartburn, Gastroesophageal Reflux Disease (GERD)
Clinical Study IdentifierTX291181
SponsorPhantom Pharmaceuticals
Last Modified on8 August 2022

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