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

NCT06284876 — Phase 3, Recruiting, 416 participants, Il-Yang Pharm. Co., Ltd.

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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

Registry	NCT06284876
Status	Recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	416 (Estimated)
Sponsor	Il-Yang Pharm. Co., Ltd. (Industry)
Conditions	Peptic Ulcer
Interventions	Ilaprazole, Lansoprazole, Ilaprazole Placebo, Lansoprazole Placebo (Drug)
Dates	start 2024-07-23, primary completion 2026-08-30 (estimated), completion 2027-02-28 (estimated), first posted 2024-02-29, last updated 2025-05-30
Locations	2 sites in South Korea

-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

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+Detailed description

Not provided

+Arms and interventions

Arm	Type	Interventions	Description
Ilaprazole 10 mg	Experimental	Drug: Ilaprazole; Drug: Lansoprazole Placebo	Take Ilaprazole 10 mg 1 tablet + Placebo of Lansoprazole 15 mg 1 capsule by mouth, with water, once daily.
Lansoprazole 15 mg	Active comparator	Drug: Lansoprazole; Drug: Ilaprazole Placebo	Take Lansoprazole 15 mg 1 capsule + Placebo of Ilaprazole 10 mg 1 tablet by mouth, with water, once daily.

Ilaprazole (Drug), also known as Noltec(the brand name): Ilaprazole 10 mg
Lansoprazole (Drug), also known as Lanston(the brand name): Lansoprazole 15 mg
Ilaprazole Placebo (Drug), also known as Ilaprazole Placebo-matching tablet: Placebo of Ilaprazole 10 mg
Lansoprazole Placebo (Drug), also known as Lansoprazole Placebo-matching tablet: Placebo of Lansoprazole 15 mg

+Outcome measures

Primary outcomes

Ilaprazole, Lansoprazole peptic ulcer [at 24 weeks]: Proportion of subjects with newly developed peptic ulcer until Week 24 after the IP treatment

Secondary outcomes

Ilaprazole, Lansoprazole peptic ulcer [at 12 weeks]: Proportion of subjects with newly developed peptic ulcer until Week 12 after the IP treatment
Ilaprazole, Lansoprazole GI bleeding [at 12, 24 weeks]: Proportion of subjects with upper GI bleeding by Week 12 and Week 24 after the IP treatment

+Eligibility

Sex: All, ages: 19 Years to any

Inclusion Criteria:

1. Adult males and females aged 19 years or older on the day of informed consent
2. Subjects requiring continuous treatment or receiving treatment with NSAIDs
3. Subjects with at least one of following peptic ulcer risk factors at the time of Screening
4. Subjects who have provided voluntary informed consent for the study participation after the study is explained

Exclusion Criteria:

1. Subjects with Gastroesophageal varices, Esophageal stricture or ulcerous stenosis, Gastrointestinal bleeding or perforation, Esophageal dysplasia and else based on the screening EGD results.
2. Subjects with inflammatory bowel diseases, pancreatitis, pyloric obstruction, and primary esophageal motility disorder
3. Subjects with confirmed history of malignancy within 5 years prior to Screening
4. Positive human immunodeficiency virus (HIV) antigen/antibody at Screening

+Locations (2)

Facility	City	Country	Status
Chung Ang University Hospital	Seoul	South Korea	Recruiting
Chung-Ang University Hospital	Seoul	South Korea	Recruiting

+Investigators

JungSoo Song, M.D., Principal investigator, Chung-Ang University Hospital Center