A Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer
Abstract
The study aims to demonstrate the preventive effect of DWP14012 20 mg for peptic ulcer is non-inferior to that of Lansoprazole 15 mg in terms of prevention of peptic ulcer and confirm the safety of DWP14012 20 mg.
Conditions: Peptic Ulcer.
Primary outcome: Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator.
Enrollment: 423 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: 423 participants or records.
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