Study to Evaluate the Efficacy and Safety of Fexuprazan in Prevention of NSAIDs Induced Peptic Ulcer
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorDaewoong Pharmaceutical Co. LTD.
About this trial
The study aims to demonstrate the preventive effect of Fexuprazan 20 mg for peptic ulcer is non-inferior to that of Lansoprazole 15 mg in terms of prevention of peptic ulcer and confirm the safety of Fexuprazan 20 mg.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female adults aged ≥ 19 years at the time of informed consent
Subjects who are diagnosed with musculoskeletal disease at screening and require continued treatment with NSAIDs for at least 24 weeks
Subjects with at least one of the following risk factors for ulcer development at screening.
Subjects who have no gastric or duodenal mucosal break or have ulcer in the scarring stage based on the EGD result at screening.
Disqualifiers
Subjects with esophagitis, gastroesophageal varix, esophagus, Barrett's esophagus, acute gastrointestinal bleeding and else based on the screening EGD results.
Subjects who have undergone gastroduodenal surgery or total small bowel resection
Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system
Subjects who have had a malignant tumor in the last 5 years
Trial design
Design model
Parallel
Treatments tested in this trial
Fexuprazan 20mg
DrugFexuprazan 20mg, tablet, orally, once daily for up to 24 weeks
Lansoprazole 15 mg placebo
DrugLansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks
Lansoprazole 15 mg
DrugLansoprazole 15mg capsule, orally, once daily for up to 24 weeks
Fexuprazan 20mg placebo
DrugFexuprazan 20mg placebo-matching tablet, orally, once daily for up to 24 weeks
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Fexuprazan 20mgExperimental treatment 2 interventions
Group B: Lansoprazole 15mgActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator
Time frame
From enrollment to the end of treatment at 24 weeksSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: