Helicobacter Pylori
Conditions
Brief summary
This is an open-label, randomized controlled study. The study plans to enroll 414 subjects with Helicobacter pylori infection, who will be randomly assigned to the experimental group (Keverprazan dual therapy for 10 days or Keverprazan dual therapy for 14 days) or the control group (Rabeprazole quadruple therapy for 14 days) at a ratio of 1:1:1.
Detailed description
This is an open-label, randomized controlled study. The study plans to enroll 414 subjects with Helicobacter pylori infection, who will be randomly assigned to the experimental group (Keverprazan dual therapy for 10 days or Keverprazan dual therapy for 14 days) or the control group (Rabeprazole quadruple therapy for 14 days) at a ratio of 1:1:1. Study duration: Starting from the date of ethics approval and clinical registration completion, the project will last for 1 year. If you agree to participate in this study, you will be assigned to one of the three treatment groups through randomization (with a 33% probability for each group), with 138 subjects in each group. The study is divided into a screening phase and a treatment phase, with a total of 4 visit points: Screening period: -7 to 0 days 1. Obtain informed consent; 2. Collect demographic information and baseline characteristics of the subject; 3. Record medical history and current treatment, concomitant medications (including prescription and over-the-counter drugs); 4. Vital signs, physical examination; 5. H. pylori test; 6. Review inclusion and exclusion criteria; 7. Eligible subjects will be randomized to receive assigned treatment based on randomization numbers. Visit period V2 (telephone visit): K10 group: 10 days (±3 days), K14 group: 14 days (±3 days), R14 group: 14 days (±3 days) 1. Vital signs, physical examination; 2. Record concomitant medications; 3. Record adverse events after medication. Visit period V3: 9 weeks (±7 days) 1\) Vital signs, physical examination; 2) H. pylori test; 3) Record concomitant medications; 4) Record adverse events after medication.
Interventions
DRUGKeverprazan 10 days
Keverprazan dual therapy for 10 days (K10 group): Keverprazan 20 mg per dose, twice daily (bid) + Amoxicillin 1 g per dose, three times (tid) daily, for 10 days.
DRUGKeverprazan 14 days
Keverprazan dual therapy for 14 days (K14 group): Keverprazan 20 mg, bid + Amoxicillin 1 g, tid, for 14 days.
DRUGRabeprazole
Rabeprazole quadruple therapy for 14 days (R14 group): Rabeprazole sodium 10 mg + Amoxicillin 1 g + Clarithromycin 500 mg + Colloidal pectin bismuth 200 mg, bid, for 14 days.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adult patients aged 18 to 65 years old, regardless of gender; 2. H. pylori positive, diagnosed a 13C-urea breath test (13C-UBT), ¹⁴C-urea breath test (¹⁴C-UBT), H&E staining or bacterial culture; 3. No previous history of H. pylori eradication therapy; 4. Subjects able to independently complete the recording of the subject diary card; 5. Subjects who fully understand the trial content, voluntarily participate in the trial, can complete the trial process, and sign the informed consent form.
Exclusion criteria
1. Use of acid-suppressing drugs such as proton pump inhibitors (PPIs), potassium-competitive acid blocker (P-CAB), H2 receptor antagonists, etc., within 2 weeks before enrollment, or use of antibiotics within 4 weeks before enrollment; 2. Active peptic ulcer with complications such as bleeding, perforation, obstruction, canceration, etc.; 3. Previous history of esophageal or gastric surgery; 4. Severe systemic diseases, including diseases of major organs dysfunction such as (cardiac, pulmonary, cerebral), hepatic or renal impairment, malignant neoplasms , or other diseases; 5. Participants with allergies or hypersensitivity to keverprazan, rabeprazole, amoxicillin, clarithromycin, bismuth agents, including its excipients (such as mannitol, microcrystalline cellulose, crospovidone, hypromellose, magnesium stearate, etc.); 6. Female participants who are pregnant, breastfeeding; 7. Long-term alcohol abuse or any other conditions that increase the risk of treatment-related adverse events; 8. Participation in other studies within the past 3 months, inability to clearly express oneself, or inability to cooperate with investigators; 9. Deemed unsuitable for participation in the study by the investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| H. pylori eradication rate 6-8 weeks after the end of eradication treatment | 8-10weeks | Efficacy Endpoints: The primary efficacy endpoint is the proportion of subjects achieving successful Helicobacter pylori eradication 6-8 weeks after completion of first-line therapy. Eradication rates will be reported with two-sided 95% confidence intervals (CIs) calculated using the Clopper-Pearson method. Inter-group differences will be estimated along with their 95% CIs using the Miettinen-Nurminen method. Inter-group comparisons will be performed using the chi-square test or Fisher's exact test, as appropriate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | From first dose of study drug until 8 weeks after last dose | Through the incidence, severity (per CTCAE v5.0), and drug-drug interactions of adverse events (AEs) occurring from the start of medication until 8 weeks after the end of medication. |
Countries
China
Contacts
Primary ContactJUN YE
Outcome results
None listed