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

  • STATUS
    Recruiting
  • sponsor
    Phantom Pharmaceuticals
Updated on 20 September 2021

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.

This study will consist of 5 visits (4 in person and 1 phone call) to the study location over the next 16 weeks. The study has 4 periods which include: Screening Period (up to 5 weeks), the Run-in Period (4 weeks), the On-Demand Study Treatment Period (6 weeks) and a follow-up visit that will occur 1 week after completing the On-Demand Study Treatment Period. There will be compensation for time and travel. 

Details
Condition Heartburn, Gastroesophageal Reflux Disease (GERD), Heartburn (Pediatric), Non-Erosive Reflux Disease (NERD)
Clinical Study IdentifierTX270106
SponsorPhantom Pharmaceuticals
Last Modified on20 September 2021

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