AzTrials
AzTrials

Gastric UlcerPhase 3NCT05448001

Clinical Trial to Evaluate the Efficacy and Safety of JP-1366 in Patients With Gastric Ulcer

A Phase 3 study testing JP-1366 20mg and Lansoprazole 30mg in people with Gastric Ulcer, run by Onconic Therapeutics Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A Multi-center, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase III Clinical Trial to Evaluate the Efficacy and Safety of JP-1366 in Patients with Gastric Ulcer Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Gastric Ulcer
What is being tested?
JP-1366 20mg and Lansoprazole 30mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
329 participants
Where
1 siteSouth Korea
Study dates
19 Sep 2022to 19 Jul 2024
Phase
Phase 3
Are there results?
None posted in the registry

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
  • Inclusion Criteria: Subjects who meet all of the following criteria can participate in this study:
  1. Male or female, ≥ 19 years of age at the time of obtaining consent
  2. Confirmation via upper gastrointestinal endoscopy within 14 days from Visit 2 for the following: º One or more GUs with the largest ulcer ≥ 3 mm to ≤ 30 mm º Largest ulcer classified as A1 or A2 based on Sakita-Miwa classification
  3. Subjects who fully understand this study and voluntarily signed the informed consent form
  • Exclusion Criteria: Subjects who meet any of the following criteria cannot participate in this trial:

[Medical History]

  1. Subjects who have undergone gastric acid secretion suppression surgery, gastric surgery (e.g., gastrectomy and gastromucosectomy), resection of entire small bowel (excluding simple ulcer closure and endoscopic benign tumor resection) or esophageal surgery
  2. Subjects with history of Zollinger-Ellison syndrome or gastric hypersecretion
  3. Subjects with hypersensitivity (present or past) to any substance in the IP, drugs in the same class as them (potassium-competitive acid blocker [P-CAB] and proton pump ingibitor[PPI]), or benzimidazole
  4. Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  5. Subjects with malignant gastrointestinal cancer regardless of the period, Subjects with a history of malignancy within 5 years from Visit 1 (however, subjects with basal cell carcinoma or squamous cell carcinoma who require steady long-term follow-up only without therapeutic dosing/procedure/surgery, etc. can participate in this trial)
  6. Subjects with a history of drug or alcohol abuse within 1 year from Visit 1.
  7. Subjects who have had or are scheduled to have major surgery that may affect gastric acid secretion within 30 days from Visit 1 [Comorbidity]
  8. Subjects with gastrointestinal bleeding, esophageal stricture, ulcer-induced stenosis, pyloric stenosis, gastroesophageal varices, Barrett's esophagus (> 3 cm), esophageal dysplasia, duodenal ulcer, glandular ulcer, refractory ulcer, perforation ulcer, or surgery-induced ulcer at Visit 1
  9. Subjects with signal symptoms (dysphagia, severe dysphagia, bleeding, weight loss, anemia, and bloody stools) that suggest malignant tumors of gastrointestinal tract at Visit 1 (except a tumor confirmed negative in endoscopy, etc.)
  10. Subjects with pancreatitis, inflammatory bowel Disease (Crohn's disease, ulcerative colitis, or Behcet's enteritis) at Visit 1
  11. Subjects with known acquired immune deficiency syndrome (AIDS) or hepatitis (including Hepatitis B surface (HBs) antigen positive, Hepatitis C virus (HCV) antibody positive, or hepatitis virus carrier) (except subjects that are HCV-RNA negative)
  12. Subject with clinically significant mental illness
  13. Thrombotic patients (cerebral thrombosis, myocardial infarction, thrombophlebitis, etc.)
  14. Subjects who confirmed malignant tumors by upper gastrointestinal endoscopy during the Screening (Visit 1). If a biopsy is required. Subject who may have an impact on the lesion evaluated in this clinical trial needs to be excluded, and the biopsy should not be delayed for registration in this clinical trial. [Drug Dosing/Treatment History]
  15. Subjects with a history of taking any of the following drugs or those required to take them until the end of treatment (EOT): For participation in this trial, stable drugs must not be discontinued.: <Drugs prohibited from within 2 weeks of Visit 1 to EOT> º All acid blockers other than the IPs: H2 receptor antagonists, proton pump inhibitors (PPIs) and potassium-competitive gastric acid blockers º Gastromucosal protection agents: Prostaglandins (however, local administration is allowed) and mucosal blood flow stimulants Antacids º Gastrointestinal motility stimulants º Anticholinergics (however, local administration is allowed) º Cholinergic agents (however, local administration is allowed) º Glucocorticosteroids (however, local administration is allowed) º Gastrin receptor antagonist, other drugs for the treatment of peptic ulcer <Drugs prohibited from Visit 1 to EOT> º Rilpivirine, atazanavir, and nelfinavir º Antipsychotics, antidepressants, and antianxiety drugs <1 week prior to the date of upper gastrointestinal endoscopy(EGD)> º Non-steroidal anti-inflammatory drugs (NSAIDs) º Antithrombotic agents: Anticoagulants or antiplatelet drugs However, among the above drugs, drugs administered as a pre-treatment for upper gastrointestinal endoscopy or for an urea breath test are allowed : midazolam, propofol, simethicone, hyoscine butylbromide, cimetropium bromide, magmil, pethidine, gasocol, urea, etc.
  16. Subjects who have participated in another clinical trial within 4 weeks from Visit 1 and have been administered with or used an IP or medical device at least once
  17. Subjects who have received H.pylori eradication treatment within 4 weeksfrom the date of upper gastrointestinal endoscopy.
  18. Subjects who have clinically significant abnormal electrocardiogram [Laboratory Tests]
  19. Blood test results meet the criteria below at Visit 1: º ALT, AST, ALP, GGT, Total bilirubin > 2.0 x ULN º eGFR < 60 mL/min/1.73 m2 [Other]
  20. Subjects who cannot undergo upper gastrointestinal endoscopy
  21. Pregnant or breast-feeding women
  22. Women and men of childbearing potential who are unwilling to use an appropriate medically acceptable method of contraception during the entire study period (Visit 1 through the end of study visit)
  23. Subjects who are judged unsuitable for participation in this trial by the investigators for other reasons

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Korea University Kuro Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Multi-center, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase III Clinical Trial to Evaluate the Efficacy and Safety of JP-1366 in Patients With Gastric Ulcer

A Multi-center, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase III Clinical Trial to Evaluate the Efficacy and Safety of JP-1366 in Patients with Gastric Ulcer

Conditions
Gastric Ulcer
Being tested
JP-1366 20mg, Lansoprazole 30mg
Medical subject headings
Stomach Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JP-1366 20mgDrug

    JP-1366 20 mg 1 capsule, Lansoprazole 30 mg placebo 1 capsule before meal

  • Lansoprazole 30mgDrug

    JP-1366 20 mg placebo 1 capsule, Lansoprazole 30 mg 1 capsule before meal

Study groups in NCT05448001
Study groupRoleWhat they receive
Study GroupExperimentalNot described
Receives: Drug: JP-1366 20mg
Control GroupActive comparatorNot described
Receives: Drug: Lansoprazole 30mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative complete healing rate for ulcer confirmed by upper gastrointestinal endoscopy by Week 8

    Measured: Week 8

Secondary outcomes (7)
  1. Complete healing rate for ulcers confirmed by upper gastrointestinal endoscopy at Week 4

    Measured: Week 4

  2. Complete healing rate for ulcer confirmed by upper gastrointestinal endoscopy at Week 4 by Helicobacter pylori infection status

    Measured: Week 4

  3. Cumulative complete healing rate for ulcer confirmed by upper gastrointestinal endoscopy according to Helicobacter pylori infection status by Week 8

    Measured: Week 8

  4. Changes of Gastrointestinal symptoms per NDI-K at week 4 and 8

    The frequency and severity of 15 gastointestinal symptoms were scored on a scale from 0 to 4 using a score sheet.

    Measured: Week 4 and 8

  5. Changes in quality of life (EQ-5D-5L) at Weeks 4 and 8

    Measured: Week 4 and 8

  6. Changes and the proportion of changes of the ulcer size(s) at week 4 and week 8

    Subjects will also rate their health status on the visual analogue scale (VAS) between 0 (the worst state) and 100 (the best state) to get the score for their overall health.

    Measured: Week 4 and 8

  7. Change of the number of ulcer(s) at week 4 and week 8

    Measured: Week 4 and 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2022
  2. Study start19 Sep 2022
  3. Primary completion10 Jul 2024
  4. Study completion19 Jul 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
329 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05448001
Sponsor's protocol ID
JP-1366-303
Status last verified
Aug 2024
First submitted
28 Jun 2022
Last updated
26 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Park KS, Kim HS, Oh JH, Chung WC, Choi SC, Lee SH, Kim TH, Cheung DY, Baik GH, Kim SM, Lee HL, Moon JS, Choi CW, Sohn C, Kim KO, Kim BW, Jung HK, Jung DH, Kim SS, Park MI, Lee JY, Kim GH, Moon HS, Chun H, Shim KN, Shin WG, Park CH, Kim T, Jung SW, Kim H, Jee SR, Lee K, Cho YK, Park SC, Cho J, Huh C, Kwon H, Kim J, Kim J, Park JJ. Randomized, Double-Blind, Active-Controlled, Parallel, Phase 3 Clinical Trial for Evaluating the Efficacy and Safety of Zastaprazan in Patients with Gastric Ulcers. Gut Liver. 2026 Jul 15;20(4):562-574. doi: 10.5009/gnl250334. Epub 2026 Jan 16.

    PubMed 41540828

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JP-1366 20mg and Lansoprazole 30mg in people with Gastric 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?

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: finished, as of the sponsor's last update on 26 Aug 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Cumulative complete healing rate for ulcer confirmed by upper gastrointestinal endoscopy by Week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05448001, which also lists 1 linked publication.

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 26 Aug 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in