Comparing two treatments for Helicobacter pylori infection
Comparison of the Efficacy of Tegoprazan-containing Versus Esomeprazole-containing Dual Therapy for Helicobacter Pylori Eradication: a Prospective, Multicenter, Randomized Controlled Study （SHARE2301）
NA · Shandong University · NCT05870683
This study is testing whether a new combination of medications can effectively treat Helicobacter pylori infection in people and help prevent stomach cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 368 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Shandong University (other) |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05870683 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two dual therapies for the first-line treatment of Helicobacter pylori infection, a common gastrointestinal disease that can lead to stomach cancer. The study will evaluate the use of tegoprazan, a potassium-competitive acid blocker, in combination with amoxicillin and esomeprazole. Previous studies have shown high eradication rates with dual therapy, and this trial seeks to verify the efficacy of tegoprazan in clinical settings. Participants will be monitored for treatment outcomes and side effects over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with Helicobacter pylori infection who have not previously undergone eradication therapy.
Not a fit: Patients with serious underlying health conditions or those who have received certain medications recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and safer treatment option for patients with Helicobacter pylori infection.
How similar studies have performed: Previous studies have shown high success rates with dual therapy approaches for Helicobacter pylori eradication, indicating that this method is well-supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Helicobacter pylori infection (either positive for histopathological test, rapid urease test, or C13/C14 urea breath test). * Patients who have not previously received helicobacter pylori eradication therapy. Exclusion Criteria: * Serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, malignant tumor, coronary heart disease (angina pectoris or coronary artery stenosis ≥ 75%). * Those who are not willing to take contraceptive measures during pregnancy, lactation or the trial. * Active gastrointestinal bleeding. * History of drug allergy. * History of upper gastrointestinal surgery. * Medication history of bismuth, antibiotics and PPI within 4 weeks. * Other behaviors that may increase the risk, such as alcohol and drug abuse. * Unable or unwilling to provide informed consent.
Where this trial is running
Jinan, Shandong
- Department of Gastroenterology, Qilu Hospital, Shandong University — Jinan, Shandong, China (RECRUITING)
Study contacts
- Study coordinator: Yanqing Li, MD
- Email: qlxhkqz@163.com
- Phone: 18560086667
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Helicobacter Pylori Infection