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

Il-Yang Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Peptic Ulcer

Treatments: Drug: Lansoprazole Placebo; Drug: Lansoprazole; Drug: Ilaprazole; Drug: Ilaprazole Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06284876

IY-NTNS03

Details and patient eligibility

About

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

Full description

Not provided

Enrollment: 416 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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416 participants in 2 patient groups

Ilaprazole 10 mg

Experimental group

Description:

Take Ilaprazole 10 mg 1 tablet + Placebo of Lansoprazole 15 mg 1 capsule by mouth, with water, once daily.

Treatment:

Drug: Ilaprazole

Drug: Lansoprazole Placebo

Lansoprazole 15 mg

Active Comparator group

Description:

Take Lansoprazole 15 mg 1 capsule + Placebo of Ilaprazole 10 mg 1 tablet by mouth, with water, once daily.

Treatment:

Drug: Ilaprazole Placebo

Drug: Lansoprazole