NCT04124926

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis

A Phase 3, Randomized, Double-Blind, Two Phase, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 20 mg Compared to Lansoprazole 30 mg for Healing in Patients With Erosive Esophagitis and to Evaluate the Efficacy and Safety of Vonoprazan (10 mg and 20 mg) Compared to Lansoprazole 15 mg for the Maintenance of Healing in Patients With Healed Erosive Esophagitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,027 (actual)
• Sponsor: Phathom Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of vonoprazan compared to lansoprazole in participants with erosive esophagitis.

Conditions

• Erosive Esophagitis

Interventions

Type	Name	Description
DRUG	Vonoprazan	Over-encapsulated tablet administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.
DRUG	Lansoprazole	Over-encapsulated capsule administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.

Timeline

• Start date: 2019-10-28
• Primary completion: 2021-07-29
• Completion: 2021-08-24
• First posted: 2019-10-14
• Last updated: 2022-07-29
• Results posted: 2022-07-29

Locations

157 sites across 6 countries: United States, Bulgaria, Czechia, Hungary, Poland, United Kingdom

Regulatory

• FDA-regulated drug study