ClinicalTrials.gg
Active, not recruitingNCT06284876Updated Nov 6, 2026

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

A Phase 3 interventional study of Ilaprazole and Lansoprazole in Peptic Ulcer, sponsored by Il-Yang Pharm. Co., Ltd.. Active, not recruiting at 2 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Il-Yang Pharm. Co., Ltd. · Phase 3, Interventional, and Prevention

Updated Nov 6, 2026Now Active, not recruitingPrimary completion moved+1 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
416
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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

Read the detailed description

Not provided

02

Conditions studied

  • Peptic Ulcer

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03

In context

Peptic Ulcer

146 studies on the registry are indexed under Peptic Ulcer; 25 are open to participants now.

This study's planned enrollment of 416 is above the median of 165 across 105 interventional studies indexed under Peptic Ulcer.

Browse Peptic Ulcer studies →

Lead sponsor

Il-Yang Pharm. Co., Ltd. is the lead sponsor of 34 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adult males and females aged 19 years or older on the day of
  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

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 within 5 years prior to Screening
  4. Positive (HIV) antigen/antibody at Screening
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
416 participants (estimated)

Study arms

  • 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 · Drug: Lansoprazole Placebo

  • 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 · Drug: Ilaprazole Placebo

Interventions

  • Ilaprazole 10 mg

    Also known as: Noltec(the brand name)

  • Lansoprazole 15 mg

    Also known as: Lanston(the brand name)

  • DrugIlaprazole Placebo

    Placebo of Ilaprazole 10 mg

    Also known as: Ilaprazole Placebo-matching tablet

  • DrugLansoprazole Placebo

    Placebo of Lansoprazole 15 mg

    Also known as: Lansoprazole Placebo-matching tablet

06

What researchers measure

Primary outcomes

  1. Ilaprazole, Lansoprazole peptic ulcer

    Proportion of subjects with newly developed peptic ulcer until Week 24 after the IP treatment

    Time frame: at 24 weeks

Secondary outcomes

  1. Ilaprazole, Lansoprazole peptic ulcer

    Proportion of subjects with newly developed peptic ulcer until Week 12 after the IP treatment

    Time frame: at 12 weeks

  2. Ilaprazole, Lansoprazole GI bleeding

    Proportion of subjects with upper GI bleeding by Week 12 and Week 24 after the IP treatment

    Time frame: at 12, 24 weeks

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Nov 6, 2026
Primary completion
Aug 30, 2026→Aug 30, 2027
Nov 6, 2026
Study completion
Feb 28, 2027→Feb 28, 2028
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Recruiting→Active, not recruiting
    Primary completion Aug 30, 2026→Aug 30, 2027
    Study completion Feb 28, 2027→Feb 28, 2028
    + 4 other changes: verification date, contact details, site details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06284876
Responsible party
Sponsor
First posted
Feb 29, 2024
Start date
Jul 23, 2024
Primary completion
Aug 30, 2027 (estimated)
Completion
Feb 28, 2028 (estimated)
Last update
Nov 6, 2026

Study contacts

JungSoo Song, M.D.
principal investigator · Chung-Ang University Hospital Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Ilaprazole

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