Study to Evaluate the Efficacy and Safety of DWP14012-based Triple Therapy in Eradication of Heli… (NCT06751121) | Clinical Trial Compass
CompletedPhase 3
Study to Evaluate the Efficacy and Safety of DWP14012-based Triple Therapy in Eradication of Helicobacter Pylori
South Korea461 participantsStarted 2024-02-06
Plain-language summary
This study is designed to demonstrate the non-inferiority and verify the safety of DWP14012-based triple therapy compared to DWC202301-based triple therapy as the first-line eradication therapy in patients who are positive for Helicobacter pylori
Who can participate
Age range19 Years – 75 Years
SexALL
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Inclusion criteria
✓. Adult males and females ≥19 and ≤75 years of age at the time of giving informed consent
✓. Those who have all positive test results for H. pylori (13C-urea breath test and CLO) at screening visit (Visit 1)
✓. Those who require treatment for H. pylori eradication as at least one of the following applies:
Exclusion criteria
✕. Those with significant upper GI bleeding
✕. Those with a history of a surgical procedure that might affect gastric acid secretion (upper GI resection or vagotomy), or who are scheduled to undergo such procedure during this study
✕. Those with Zollinger-Ellison syndrome or other gastric acid hypersecretion disorders
✕. Those with a history of treatment for H. pylori eradication
✕. Those with a history of any malignancy within recent 5 years prior to screening visit (Visit 1)
✕. Those who have experienced acute coronary artery disease (unstable angina, myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention), peripheral arterial disease and cerebrovascular disease (transient ischemic attack, stroke) within 24 weeks prior to screening visit (Visit 1)
✕. Those with clinically significant systemic bleeding disorders, coagulation disorders, or severe blood disorders that make them ineligible for participation in this study
✕
What they're measuring
1
H. pylori eradication rate
Timeframe: after at least 4 weeks (28 - 56 days) from the end of treatment
. Those with acquired immunodeficiency syndrome (AIDS) or viral hepatitis (tested positive for HBs antigen or HCV antibody) (However, subjects who are negative for HCV-RNA can participate.)