Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic Ulcers

Peptic Ulcer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06439563
• Other study ID #: JP-1366-304
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 2024
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: Onconic Therapeutics Inc.
• Contact: John KIM
• Phone: 0234540780
• Email: onconictherapeutics[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 364
• Est. completion date: December 2027
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Adult male/female aged 19 years or older as of the date of obtaining consent

2. 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

3. Those with one or more of the following risk factors for ulcer development at the time of screening

4. Subjects who fully understand this study and voluntarily signed the informed consent form.

Exclusion Criteria:

1. Those who cannot undergo upper gastrointestinal endoscopy

2. 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*

3. Those with a confirmed history of malignant tumor within 5 years

4. Those with a confirmed history of signal symptoms suggestive of malignant disease of the gastrointestinal tract

5. Those who need to continuously take corticosteroids, antiplatelet agents, and

anticoagulants during this study (however, the following cases are permitted):

6. Pregnant and lactating women or those with a positive pregnancy test result at screening

7. 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)

Related Conditions & MeSH terms

• Peptic Ulcer
• Ulcer

Intervention

Drug:
• JP-1366 10 mg
JP-1366 10 mg, tablet, orally once a day for up to 24 weeks
• Lanston Capsule 15 mg
Lanston Capsule 15 mg orally once a day for up to 24 weeks
• JP-1366 10 mg placebo
JP-1366 10 mg placebo, tablet, orally once a day for up to 24 weeks
• Lanston Capsule 15 mg placebo
Lanston Capsule 15 mg placebo, orally once a day for up to 24 weeks

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Onconic Therapeutics Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative proportion of subjects who developed peptic ulcers		at 24 weeks after administration of investigational products
Secondary	Proportion of subjects with gastric or duodenal endoscopic bleeding		at 24 weeks after administration of investigational products