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

Peptic Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06284876
• Other study ID #: IY-NTNS03
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 30, 2024
• Est. completion date: February 28, 2027

Study information

• Verified date: February 2024
• Source: Il-Yang Pharm. Co., Ltd.
• Contact: JungHwa Hong, Master
• Phone: +82.2.570.3777
• Email: jhhong[@]ilyang.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Not provided

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 416
• Est. completion date: February 28, 2027
• Est. primary completion date: August 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peptic Ulcer
• Ulcer

Intervention

Drug:
• Ilaprazole
Ilaprazole 10 mg
• Lansoprazole
Lansoprazole 15 mg
• Ilaprazole Placebo
Placebo of Ilaprazole 10 mg
• Lansoprazole Placebo
Placebo of Lansoprazole 15 mg

Locations

Country	Name	City	State
Korea, Republic of	Chung Ang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Il-Yang Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ilaprazole, Lansoprazole peptic ulcer	Proportion of subjects with newly developed peptic ulcer until Week 24 after the IP treatment	at 24 weeks
Secondary	Ilaprazole, Lansoprazole peptic ulcer	Proportion of subjects with newly developed peptic ulcer until Week 12 after the IP treatment	at 12 weeks
Secondary	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