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

Phase 3

Not yet recruiting

• Conditions: Peptic Ulcer
• Interventions: Drug: Ilaprazole; Drug: Lansoprazole; Drug: Ilaprazole Placebo; Drug: Lansoprazole Placebo

• Registration Number: NCT06284876
• Lead Sponsor: Il-Yang Pharm. Co., Ltd.

Brief 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

Detailed Description

Not provided

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-02-27
• Last Update Submitted: 2024-02-27
• Study First Posted: 2024-02-29
• Last Update Posted: 2024-02-29
• Study Start: 2024-08-30
• Primary Completion: 2026-08-30
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 416

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Ilaprazole, Lansoprazole peptic ulcer	at 24 weeks	Proportion of subjects with newly developed peptic ulcer until Week 24 after the IP treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chung Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of