Peptic UlcerPhase 3NCT06284876
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
A Phase 3 study testing Ilaprazole and Lansoprazole in people with Peptic Ulcer, run by Il-Yang Pharm. Co., Ltd. at 2 sites in South Korea.
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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Peptic Ulcer
- What is being tested?
- Ilaprazole and Lansoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 416 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 23 Jul 2024to 28 Feb 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males and females aged 19 years or older on the day of informed consent
- Subjects requiring continuous treatment or receiving treatment with NSAIDs
- Subjects with at least one of following peptic ulcer risk factors at the time of Screening
- Subjects who have provided voluntary informed consent for the study participation after the study is explained
Who cannot join
- Subjects with Gastroesophageal varices, Esophageal stricture or ulcerous stenosis, Gastrointestinal bleeding or perforation, Esophageal dysplasia and else based on the screening EGD results.
- Subjects with inflammatory bowel diseases, pancreatitis, pyloric obstruction, and primary esophageal motility disorder
- Subjects with confirmed history of malignancy within 5 years prior to Screening
- Positive human immunodeficiency virus (HIV) antigen/antibody at Screening
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Chung Ang University Hospital
Seoul
Chung-Ang University Hospital
Seoul
About this study
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
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
- Conditions
- Peptic Ulcer
- Being tested
- Ilaprazole, Lansoprazole, Ilaprazole Placebo, Lansoprazole Placebo
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IlaprazoleDrug
Also called Noltec(the brand name)
Ilaprazole 10 mg
LansoprazoleDrug
Also called Lanston(the brand name)
Lansoprazole 15 mg
Ilaprazole PlaceboDrug
Also called Ilaprazole Placebo-matching tablet
Placebo of Ilaprazole 10 mg
Lansoprazole PlaceboDrug
Also called Lansoprazole Placebo-matching tablet
Placebo of Lansoprazole 15 mg
| Study group | Role | What they receive |
|---|---|---|
| Ilaprazole 10 mg | Experimental | Take Ilaprazole 10 mg 1 tablet + Placebo of Lansoprazole 15 mg 1 capsule by mouth, with water, once daily. Receives: Drug: Ilaprazole; Drug: Lansoprazole Placebo |
| Lansoprazole 15 mg | Active comparator | Take Lansoprazole 15 mg 1 capsule + Placebo of Ilaprazole 10 mg 1 tablet by mouth, with water, once daily. Receives: Drug: Lansoprazole; Drug: Ilaprazole Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ilaprazole, Lansoprazole peptic ulcer
Proportion of subjects with newly developed peptic ulcer until Week 24 after the IP treatment
Measured: at 24 weeks
Secondary outcomes (2)
Ilaprazole, Lansoprazole peptic ulcer
Proportion of subjects with newly developed peptic ulcer until Week 12 after the IP treatment
Measured: at 12 weeks
Ilaprazole, Lansoprazole GI bleeding
Proportion of subjects with upper GI bleeding by Week 12 and Week 24 after the IP treatment
Measured: at 12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start23 Jul 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JungSoo Song, M.D., Principal investigator, Chung-Ang University Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284876
- Sponsor's protocol ID
- IY-NTNS03
- Status last verified
- Nov 2026
- First submitted
- 21 Feb 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06284876
- Acronym / sponsor ID
- IY-NTNS03
- Conditions
- Peptic Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ilaprazole 10 mg | Experimental | Drug: Ilaprazole, Drug: Lansoprazole PlaceboTake Ilaprazole 10 mg 1 tablet + Placebo of Lansoprazole 15 mg 1 capsule by mouth, with water, once daily. |
| Lansoprazole 15 mg | Active comparator | Drug: Lansoprazole, Drug: Ilaprazole PlaceboTake Lansoprazole 15 mg 1 capsule + Placebo of Ilaprazole 10 mg 1 tablet by mouth, with water, once daily. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult males and females aged 19 years or older on the day of informed consent
- Subjects requiring continuous treatment or receiving treatment with NSAIDs
- Subjects with at least one of following peptic ulcer risk factors at the time of Screening
- Subjects who have provided voluntary informed consent for the study participation after the study is explained
Key exclusion criteria (4 listed)
- Subjects with Gastroesophageal varices, Esophageal stricture or ulcerous stenosis, Gastrointestinal bleeding or perforation, Esophageal dysplasia and else based on the screening EGD results.
- Subjects with inflammatory bowel diseases, pancreatitis, pyloric obstruction, and primary esophageal motility disorder
- Subjects with confirmed history of malignancy within 5 years prior to Screening
- Positive human immunodeficiency virus (HIV) antigen/antibody at Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IlaprazoleAlso: Noltec(the brand name)Ilaprazole 10 mg | Drug | Ilaprazole 10 mg |
| LansoprazoleAlso: Lanston(the brand name)Lansoprazole 15 mg | Drug | Lansoprazole 15 mg |
| Ilaprazole PlaceboAlso: Ilaprazole Placebo-matching tabletPlacebo of Ilaprazole 10 mg | Drug | Lansoprazole 15 mg |
| Lansoprazole PlaceboAlso: Lansoprazole Placebo-matching tabletPlacebo of Lansoprazole 15 mg | Drug | Ilaprazole 10 mg |
Primary outcome
Ilaprazole, Lansoprazole peptic ulcer
Time frame: at 24 weeks
Proportion of subjects with newly developed peptic ulcer until Week 24 after the IP treatment
2 secondary outcomes
Ilaprazole, Lansoprazole peptic ulcer
Time frame: at 12 weeks
Ilaprazole, Lansoprazole GI bleeding
Time frame: at 12, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JungSoo Song, M.D. principal investigator
Chung-Ang University Hospital Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ilaprazole and Lansoprazole in people with Peptic Ulcer, run by Il-Yang Pharm. Co., Ltd. at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ilaprazole, Lansoprazole peptic ulcer (time frame: at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.