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
Abstract
To evaluate the efficacy and safety of vonoprazan compared to lansoprazole in participants with erosive esophagitis.
Conditions: Erosive Esophagitis.
Primary outcome: Healing Phase: Percentage of Participants Who Had Complete Healing of EE by Week 8; Maintenance Phase: Percentage of Participants Who Maintained Complete Healing of EE at Week 24.
Enrollment: 1027 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,027 participants or records.
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