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

NCT06439563 | Recruiting Phase 3

• 1 other identifier: JP-1366-304
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peptic Ulcer

Outcome Measures

Primary Outcomes (1)

• Cumulative proportion of subjects who developed peptic ulcers

  at 24 weeks after administration of investigational products

Secondary Outcomes (1)

• Proportion of subjects with gastric or duodenal endoscopic bleeding

  at 24 weeks after administration of investigational products

Study Arms (2)

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

Interventions

JP-1366 10 mg DRUG

JP-1366 10 mg, tablet, orally once a day for up to 24 weeks

JP-1366 10 mg

Lanston Capsule 15 mg DRUG

Lanston Capsule 15 mg orally once a day for up to 24 weeks

Lanston Capsule 15 mg

JP-1366 10 mg placebo DRUG

JP-1366 10 mg placebo, tablet, orally once a day for up to 24 weeks

Lanston Capsule 15 mg

Lanston Capsule 15 mg placebo DRUG

Lanston Capsule 15 mg placebo, orally once a day for up to 24 weeks

JP-1366 10 mg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Onconic Therapeutics Inc.: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Peptic Ulcer

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Central Study Contacts

John KIM

CONTACT

0234540780; onconictherapeutics@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 3, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)