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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

416 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-23

Study Completion Date

2027-02-28

Brief Summary

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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

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Detailed Description

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Not provided

Conditions

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Peptic Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ilaprazole 10 mg

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

Group Type EXPERIMENTAL

Ilaprazole

Intervention Type DRUG

Ilaprazole 10 mg

Lansoprazole Placebo

Intervention Type DRUG

Placebo of Lansoprazole 15 mg

Lansoprazole 15 mg

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

Group Type ACTIVE_COMPARATOR

Lansoprazole

Intervention Type DRUG

Lansoprazole 15 mg

Ilaprazole Placebo

Intervention Type DRUG

Placebo of Ilaprazole 10 mg

Interventions

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Ilaprazole

Ilaprazole 10 mg

Intervention Type DRUG

Lansoprazole

Lansoprazole 15 mg

Intervention Type DRUG

Ilaprazole Placebo

Placebo of Ilaprazole 10 mg

Intervention Type DRUG

Lansoprazole Placebo

Placebo of Lansoprazole 15 mg

Intervention Type DRUG

Other Intervention Names

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Noltec(the brand name) Lanston(the brand name) Ilaprazole Placebo-matching tablet Lansoprazole Placebo-matching tablet

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No