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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Republic of Korea
Konkuk University Medical Center
RECRUITING
Seoul
Contact Information
Primary
John KIM
onconictherapeutics@gmail.com
0234540780
Time Frame
Start Date: 2024-10-22
Estimated Completion Date: 2027-12
Participants
Target number of participants: 364
Treatments
Experimental: JP-1366 10 mg
Active_comparator: Lanston Capsule 15 mg
Related Therapeutic Areas
Sponsors
Leads: Onconic Therapeutics Inc.