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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Peptic Ulcer
• Intervention / Treatment: Drug: Ilaprazole; Drug: Lansoprazole Placebo; Drug: Lansoprazole; Drug: Ilaprazole Placebo

Detailed Description

Not provided

• Study Type: Interventional
• Enrollment (Estimated): 416
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: JungHwa Hong, Master; Phone Number: +82.2.570.3777; Email: jhhong@ilyang.co.kr
• Study Contact Backup: Name: JeongSu Wi, bachelor; Phone Number: +82.2.570.3778; Email: jswi@ilyang.co.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Chung Ang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ilaprazole 10 mg; Take Ilaprazole 10 mg 1 tablet + Placebo of Lansoprazole 15 mg 1 capsule by mouth, with water, once daily.	Drug: Ilaprazole; Ilaprazole 10 mg; Other Names: Noltec(the brand name); Drug: Lansoprazole Placebo; Placebo of Lansoprazole 15 mg; Other Names: Lansoprazole Placebo-matching tablet
Active Comparator: Lansoprazole 15 mg; Take Lansoprazole 15 mg 1 capsule + Placebo of Ilaprazole 10 mg 1 tablet by mouth, with water, once daily.	Drug: Lansoprazole; Lansoprazole 15 mg; Other Names: Lanston(the brand name); Drug: Ilaprazole Placebo; Placebo of Ilaprazole 10 mg; Other Names: Ilaprazole Placebo-matching tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ilaprazole, Lansoprazole peptic ulcer	Proportion of subjects with newly developed peptic ulcer until Week 24 after the IP treatment	at 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ilaprazole, Lansoprazole peptic ulcer	Proportion of subjects with newly developed peptic ulcer until Week 12 after the IP treatment	at 12 weeks
Ilaprazole, Lansoprazole GI bleeding	Proportion of subjects with upper GI bleeding by Week 12 and Week 24 after the IP treatment	at 12, 24 weeks

Collaborators and Investigators

• Sponsor: Il-Yang Pharm. Co., Ltd.
• Investigators: Principal Investigator: JungSoo Song, M.D., Chung-Ang University Hospital Center

Study record dates

Study Major Dates

• Study Start (Estimated): August 30, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Ulcer; Peptic Ulcer; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: IY-NTNS03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No