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Tests treatment safety and results for Gastritis, Indigestion, Helicobacter Pylori Infection,...
Official title Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT07068607
What this study is testing
What is Vonoprazan?
Vonoprazan is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for gastritis, indigestion, helicobacter pylori infection, gastric cancer, peptic ulcer.
Also referred to as Vonoprazan - amoxicillin dual therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to evaluate the efficacy of vonoprazan combined with different antibiotics in dual therapy for Helicobacter pylori eradication treatment. Newly infected patients were randomly assigned to four groups: amoxicillin dual therapy, tetracycline dual therapy, minocycline dual therapy, and bismuth quadruple therapy.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Aged 18 - 70 years, regardless of gender;
- Patients with definite Hp infection (positive result in any one of the 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test) who...
- For women of child - bearing age, it is required to use medically acceptable contraceptive methods during the trial period and within 30 days after...
You likely can't join if
- Patients who have been definitely diagnosed with Hp infection and have received antibiotic eradication treatment;
- Patients with contraindications to the study drug or who are allergic to the study drug;
- Patients with severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases;
- Patients who have been continuously using anti - ulcer drugs (including taking PPI within 2 weeks before the Hp infection test), antibiotics or...
- Pregnant and lactating women;
- Patients who have undergone upper gastrointestinal surgery;
See the full eligibility criteria
- Aged 18 - 70 years, regardless of gender;
- Patients with definite Hp infection (positive result in any one of the 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test) who have never received Helicobacter pylori eradication treatment;
- For women of child - bearing age, it is required to use medically acceptable contraceptive methods during the trial period and within 30 days after the end of the trial.
- Patients who have been definitely diagnosed with Hp infection and have received antibiotic eradication treatment;
- Patients with contraindications to the study drug or who are allergic to the study drug;
- Patients with severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases;
- Patients who have been continuously using anti - ulcer drugs (including taking PPI within 2 weeks before the Hp infection test), antibiotics or bismuth complexes (more than 3 times a week within 1 month before...
- Pregnant and lactating women;
- Patients who have undergone upper gastrointestinal surgery;
- Patients with moderate or severe atypical hyperplasia or high - grade intraepithelial neoplasia;
- Patients with symptoms of dysphagia;
- Patients with evidence of bleeding or iron - deficiency anemia;
- Patients with a history of malignant tumors;
- Patients with a history of drug or alcohol abuse within the past 1 year;
- Patients who are using systemic glucocorticoids, non - steroidal anti - inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except for using aspirin ≤ 100 mg/d);
- Patients with mental disorders;
- Patients who have participated in other clinical trials within the past 3 months;
- Patients who refuse to sign the informed consent form.
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.