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NCT Number: NCT06439563

Study to Evaluate the Efficacy and Safety of JP-1366 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.

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Konkuk University Medical Center

Seoul, South Korea

Location status: Recruiting

Location contact

Sang-Heon Lee

CONTACT

0220305114

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

JP-1366 10 mg

Drug

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

Lanston Capsule 15 mg

Drug

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

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 placebo

Drug

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

Primary outcomes

  1. Cumulative proportion of subjects who developed peptic ulcers

    Time frame: at 24 weeks after administration of investigational products

Secondary outcomes

  1. Proportion of subjects with gastric or duodenal endoscopic bleeding

    Time frame: at 24 weeks after administration of investigational products

Study contacts

Contact information is provided by the study sponsor or research team.

John KIM

CONTACT

[email protected]

0234540780

Sponsors and collaborators

Lead sponsor

Onconic Therapeutics Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 3, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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