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 range
19 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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
. 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.)