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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06284876

Enrollment

416

Registered

2024-02-29

Start date

2024-07-23

Completion date

2027-02-28

Last updated

2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peptic Ulcer

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

Interventions

DRUGIlaprazole

Ilaprazole 10 mg

DRUGLansoprazole

Lansoprazole 15 mg

DRUGIlaprazole Placebo

Placebo of Ilaprazole 10 mg

DRUGLansoprazole Placebo

Placebo of Lansoprazole 15 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

South Korea

Contacts

Primary ContactJungHwa Hong, Master

jhhong@ilyang.co.kr+82.2.570.3777

Backup ContactJeongSu Wi, bachelor

jswi@ilyang.co.kr+82.2.570.3778

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026