Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic Ulcers
ConditionPeptic Ulcer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorOnconic Therapeutics Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
JP-1366 10 mg
DrugJP-1366 10 mg, tablet, orally once a day for up to 24 weeks
Lanston Capsule 15 mg
DrugLanston Capsule 15 mg orally once a day for up to 24 weeks
JP-1366 10 mg placebo
DrugJP-1366 10 mg placebo, tablet, orally once a day for up to 24 weeks
Lanston Capsule 15 mg placebo
DrugLanston Capsule 15 mg placebo, orally once a day for up to 24 weeks
Treatment groups
364 Participants
are divided into 2 treatment groupsGroup A: JP-1366 10 mgExperimental treatment 2 interventions
Group B: Lanston Capsule 15 mgActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Cumulative proportion of subjects who developed peptic ulcers
Time frame
at 24 weeks after administration of investigational productsSecondary outcomes
1
Proportion of subjects with gastric or duodenal endoscopic bleeding
Time frame
at 24 weeks after administration of investigational productsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov