Phase 3 Study Comparing Ilaprazole 10 mg and Lansoprazole 15 mg for Preventing Peptic Ulcers in Adults Taking NSAIDs

What this Trial Is About

Researchers are evaluating the effectiveness and safety of Ilaprazole 10 mg in preventing peptic ulcers associated with the use of nonsteroidal anti-inflammatory drugs NSAIDs. This phase III clinical trial aims to show that Ilaprazole is not less effective than Lansoprazole, an active control, in reducing the proportion of patients who develop peptic ulcers by 24 weeks. The study is led by Il-Yang Pharm. Co., Ltd and involves adult participants who require ongoing NSAID treatment and have risk factors for peptic ulcers. Participants are randomly assigned to one of two groups. One group takes Ilaprazole 10 mg once daily along with a placebo capsule mimicking Lansoprazole, while the other group takes Lansoprazole 15 mg once daily with a placebo tablet mimicking Ilaprazole. The study is double-blind, meaning neither the participants nor the researchers know which treatment is given. The trial includes treatment and assessment periods up to 24 weeks. During the study, participants will be monitored for the development of peptic ulcers, gastrointestinal bleeding, and other safety concerns at 12 and 24 weeks. Outcome measures focus on evaluating peptic ulcer prevention and gastrointestinal safety. The study involves multiple visits for assessments and aims to provide detailed information on the comparative effects of Ilaprazole and Lansoprazole in this patient population.

Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer