NCT05195528

A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo for Relief of Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD)

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 and 20 mg Compared to Placebo for Relief of Heartburn in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD) After 4 Weeks and to Evaluate the Efficacy and Safety of Vonoprazan 10 and 20 mg for Relief of Heartburn in Subjects With NERD After 6 Months

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 776 (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 and 20 mg once daily \[QD\]) compared to placebo (QD) in relief of heartburn over 4 weeks in participants with NERD.

Conditions

• Non-Erosive Gastro-Esophageal Reflux Disease
• Heartburn

Interventions

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

Timeline

• Start date: 2022-01-17
• Primary completion: 2022-11-21
• Completion: 2023-05-17
• First posted: 2022-01-19
• Last updated: 2023-12-29
• Results posted: 2023-12-29

Locations

108 sites across 1 country: United States

Regulatory

• FDA-regulated drug study