NCT04799158

A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease

A Phase 2, Randomized, Double-Blind, Multicenter 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 458 (actual)
• Sponsor: Phathom Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in relief of episodic heartburn over 6 weeks in participants with symptomatic non-erosive gastroesophageal reflux disease (NERD), and to assess the safety of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in participants with symptomatic NERD.

Conditions

• Non-Erosive Gastro-Esophageal Reflux Disease
• Heartburn

Interventions

Type	Name	Description
DRUG	Vonoprazan	Orally via capsules
DRUG	Placebo	Orally via capsules

Timeline

• Start date: 2021-03-25
• Primary completion: 2021-12-16
• Completion: 2022-01-17
• First posted: 2021-03-16
• Last updated: 2023-01-04
• Results posted: 2023-01-04

Locations

63 sites across 1 country: United States

Regulatory

• FDA-regulated drug study