A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
To demonstrate the non-inferiority of Ilaprazole 10 mg to the active control in prevention of NSAIDs-associated peptic ulcer, as assessed by the proportion of subjects with peptic ulcer by Week 24
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• Adult males and females aged 19 years or older on the day of informed consent
• Subjects requiring continuous treatment or receiving treatment with NSAIDs
• Subjects with at least one of following peptic ulcer risk factors at the time of Screening
• Subjects who have provided voluntary informed consent for the study participation after the study is explained
Locations
Other Locations
Republic of Korea
Chung Ang University Hospital
RECRUITING
Seoul
Chung-Ang University Hospital
RECRUITING
Seoul
Contact Information
Primary
JungHwa Hong, Master
jhhong@ilyang.co.kr
+82.2.570.3777
Backup
JeongSu Wi, bachelor
jswi@ilyang.co.kr
+82.2.570.3778
Time Frame
Start Date: 2024-07-23
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 416
Treatments
Experimental: Ilaprazole 10 mg
Take Ilaprazole 10 mg 1 tablet + Placebo of Lansoprazole 15 mg 1 capsule by mouth, with water, once daily.
Active_comparator: Lansoprazole 15 mg
Take Lansoprazole 15 mg 1 capsule + Placebo of Ilaprazole 10 mg 1 tablet by mouth, with water, once daily.
Related Therapeutic Areas
Sponsors
Leads: Il-Yang Pharm. Co., Ltd.