Helicobacter pylori infection
Conditions
Interventions
A: Tegoprazan (50mg bid) + Amoxicillin (1000mg bid) + Clarithromycin (500mg bid) + Bismuth potassium citrate (bismuth 220mg) (600mg bid) for 10 day
B:Tegoprazan (50mg bid) + Amoxicillin (1000mg bid) + Clarithromycin (500mg bid) + Bismuth potassium citrate (bismuth 220mg) (600mg bid) for 14 day
Sponsors
Nanjing Jiangbei Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Enrolled subjects must meet all of the following inclusion criteria: 1) Prior to the commencement of any study procedure, subjects voluntarily sign a written informed consent approved by the Ethics Committee to participate in the study. 2) Subjects who understand and comply with protocol requirements and agree to participate in all study visits. 3) Men or women aged =18 years and =70 years. 4) During the screening phase, Hp tested positive (13C-urea breath test) and Hp eradication therapy was determined by the investigator. 5) Subject agrees to use appropriate medical methods of contraception during the study (except medical sterilization).
Exclusion criteria
Exclusion criteria: Subjects who meet the following exclusion criteria will be excluded from this study: 1) Previously received eradication treatment for Helicobacter pylori. 2) I have participated in other clinical studies within 4 weeks prior to screening, except for the following situations: - The study in which the subject is currently or has participated is in a non-interference form (such as observational or questionnaire studies), and it is judged by the researcher that there is no interference with the efficacy and safety evaluation in the current study; The subject signed an informed consent form to participate in another study, but withdrew from the study before starting any study medication. 3) Participants who participated in the planning and execution process of this study. 4) Pregnant or lactating women. 5) Known to be effective against tegoprazan, penicillin, or other antibiotics ß Allergies to antibiotics such as lactams, macrolides, or bismuth agents (including any related excipients). If a skin sensitivity test (skin test) is required, it should be conducted according to medical procedures during visit 1. 6) Previous surgeries or procedures that may affect gastric acid secretion or drug absorption, such as subtotal gastrectomy, total gastrectomy, vagotomy, intestinal resection, etc. 7) Subjects with acute upper gastrointestinal bleeding, active gastric or duodenal ulcers, acute gastric mucosal injury, or duodenal mucosal injury under endoscopic examination. 8) According to the judgment of the researchers, the subjects suffer from uncontrolled and unstable liver, kidney, cardiovascular, respiratory, gastrointestinal, endocrine, blood, central nervous system, or mental disorders, which may affect the safety of the subjects or the interpretation of the research results. 9) Subjects who plan to be hospitalized for surgical treatment during the research process. 10) Subjects have taken H2 receptor antagonists or PPIs within 14 days prior to the 13C-urea breath test during the screening period; During the screening period (within 28 days before 13C-urea breath test), antibiotics, bismuth agents, and certain traditional Chinese medicines with antibacterial effects were taken. 11) Other situations where the researcher believes that the subject is not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| eradication rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| dverse reaction;Compliance; | — |
Countries
China
Contacts
Public ContactJianxin Ge
Nanjing Jiangbei Hospital
Outcome results
None listed