Peptic UlcerPhase 3NCT06439563
Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic Ulcers
A Phase 3 study testing JP-1366 10 mg and Lanston Capsule 15 mg in people with Peptic Ulcer, run by Onconic Therapeutics Inc. at 1 site in South Korea.
Trial summary
The sutdy aims to to demonstrate the non-inferiority of JP-1366 10 mg compared to Lanston Capsule 15 mg in preventing NSAIDs-induced peptic ulcers and to compare/evaluate the efficacy and safety of JP-1366 10 mg. 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?
- JP-1366 10 mg and Lanston Capsule 15 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 364 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Oct 2024to Dec 2027
- 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 male/female aged 19 years or older as of the date of obtaining consent
- Those who are diagnosed with musculoskeletal diseases such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, or other diseases at the time of screening and require continuous administration of NSAIDs for 24 weeks or more
- Those with one or more of the following risk factors for ulcer development at the time of screening
- Subjects who fully understand this study and voluntarily signed the informed consent form.
Who cannot join
- Those who cannot undergo upper gastrointestinal endoscopy
- At the time of screening, those who were confirmed to have active stage ulcers (A1, A2) or healing stage ulcers (H1, H2) in the stomach or duodenum according to the Sakita-Miwa Classification*
- Those with a confirmed history of malignant tumor within 5 years
- Those with a confirmed history of signal symptoms suggestive of malignant disease of the gastrointestinal tract
- Those who need to continuously take corticosteroids, antiplatelet agents, and anticoagulants during this study (however, the following cases are permitted):
- Pregnant and lactating women or those with a positive pregnancy test result at screening
- Those who participated in another study and were administered investigational products or had medical devices applied at least once within 4 weeks from the screening visit(Visit 0)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Konkuk University Medical Center
Seoul
Sang-Heon Lee, 0220305114
About this study
Official title: A Multicenter, Parallel, Double-blind, Randomized, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of JP-1366 Treatment in the Prevention of (NSAIDs)-Induced Peptic Ulcers
The sutdy aims to to demonstrate the non-inferiority of JP-1366 10 mg compared to Lanston Capsule 15 mg in preventing NSAIDs-induced peptic ulcers and to compare/evaluate the efficacy and safety of JP-1366 10 mg.
- Conditions
- Peptic Ulcer
- Being tested
- JP-1366 10 mg, Lanston Capsule 15 mg, JP-1366 10 mg placebo, Lanston Capsule 15 mg 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.
JP-1366 10 mgDrug
JP-1366 10 mg, tablet, orally once a day for up to 24 weeks
Lanston Capsule 15 mgDrug
Lanston Capsule 15 mg orally once a day for up to 24 weeks
JP-1366 10 mg placeboDrug
JP-1366 10 mg placebo, tablet, orally once a day for up to 24 weeks
Lanston Capsule 15 mg placeboDrug
Lanston Capsule 15 mg placebo, orally once a day for up to 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| JP-1366 10 mg | Experimental | Not described Receives: Drug: JP-1366 10 mg; Drug: Lanston Capsule 15 mg placebo |
| Lanston Capsule 15 mg | Active comparator | Not described Receives: Drug: Lanston Capsule 15 mg; Drug: JP-1366 10 mg placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative proportion of subjects who developed peptic ulcers
Measured: at 24 weeks after administration of investigational products
Secondary outcomes (1)
Proportion of subjects with gastric or duodenal endoscopic bleeding
Measured: at 24 weeks after administration of investigational products
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start22 Oct 2024
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (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
- 364 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onconic Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439563
- Sponsor's protocol ID
- JP-1366-304
- Status last verified
- Oct 2024
- First submitted
- 22 May 2024
- Last updated
- 1 Nov 2024
- Results posted
- 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 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Parallel, Double-blind, Randomized, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of JP-1366 Treatment in the Prevention of (NSAIDs)-Induced Peptic Ulcers
- ClinicalTrials.gov ID
- NCT06439563
- Acronym / sponsor ID
- JP-1366-304
- Conditions
- Peptic Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- Onconic Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Jun 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.
The sutdy aims to to demonstrate the non-inferiority of JP-1366 10 mg compared to Lanston Capsule 15 mg in preventing NSAIDs-induced peptic ulcers and to compare/evaluate the efficacy and safety of JP-1366 10 mg.
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 |
|---|---|---|
| JP-1366 10 mg | Experimental | Drug: JP-1366 10 mg, Drug: Lanston Capsule 15 mg placebo |
| Lanston Capsule 15 mg | Active comparator | Drug: Lanston Capsule 15 mg, Drug: JP-1366 10 mg placebo |
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 male/female aged 19 years or older as of the date of obtaining consent
- Those who are diagnosed with musculoskeletal diseases such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, or other diseases at the time of screening and require continuous administration of NSAIDs for 24 weeks or more
- Those with one or more of the following risk factors for ulcer development at the time of screening
- Subjects who fully understand this study and voluntarily signed the informed consent form.
Key exclusion criteria (7 listed)
- Those who cannot undergo upper gastrointestinal endoscopy
- At the time of screening, those who were confirmed to have active stage ulcers (A1, A2) or healing stage ulcers (H1, H2) in the stomach or duodenum according to the Sakita-Miwa Classification*
- Those with a confirmed history of malignant tumor within 5 years
- Those with a confirmed history of signal symptoms suggestive of malignant disease of the gastrointestinal tract
- Those who need to continuously take corticosteroids, antiplatelet agents, and anticoagulants during this study (however, the following cases are permitted):
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 |
|---|---|---|
| JP-1366 10 mgJP-1366 10 mg, tablet, orally once a day for up to 24 weeks | Drug | JP-1366 10 mg |
| Lanston Capsule 15 mgLanston Capsule 15 mg orally once a day for up to 24 weeks | Drug | Lanston Capsule 15 mg |
| JP-1366 10 mg placeboJP-1366 10 mg placebo, tablet, orally once a day for up to 24 weeks | Drug | Lanston Capsule 15 mg |
| Lanston Capsule 15 mg placeboLanston Capsule 15 mg placebo, orally once a day for up to 24 weeks | Drug | JP-1366 10 mg |
Primary outcome
Cumulative proportion of subjects who developed peptic ulcers
Time frame: at 24 weeks after administration of investigational products
1 secondary outcome
Proportion of subjects with gastric or duodenal endoscopic bleeding
Time frame: at 24 weeks after administration of investigational products
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 1 Nov 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JP-1366 10 mg and Lanston Capsule 15 mg in people with Peptic Ulcer, run by Onconic Therapeutics Inc. at 1 site 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 7 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: looking for participants now, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact John KIM (0234540780, onconictherapeutics@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative proportion of subjects who developed peptic ulcers (time frame: at 24 weeks after administration of investigational products). 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 1 Nov 2024.