NCT04167670

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection

A Phase 3 Randomized Multicenter Study to Evaluate the Efficacy and Safety of Open-Label Dual Therapy With Oral Vonoprazan 20 mg or Double-Blind Triple Therapy With Oral Vonoprazan 20 mg Compared to Double-Blind Triple Therapy With Oral Lansoprazole 30 mg Daily in Patients With Helicobacter Pylori Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,046 (actual)
• Sponsor: Phathom Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of Helicobacter pylori (HP) eradication with vonoprazan dual and triple therapy regimens versus lansoprazole triple therapy regimen in participants with HP infection, excluding participants who had a clarithromycin or amoxicillin resistant strain of HP at baseline.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Vonoprazan	Over-encapsulated tablets administered orally.
DRUG	Amoxicillin	Capsules administered orally.
DRUG	Clarithromycin	Tablets administered orally.
DRUG	Lansoprazole	Over-encapsulated capsules administered orally.

Timeline

• Start date: 2019-12-10
• Primary completion: 2021-03-10
• Completion: 2021-03-18
• First posted: 2019-11-19
• Last updated: 2022-04-05
• Results posted: 2022-04-05

Locations

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

Regulatory

• FDA-regulated drug study