helicobacter pylori infection
Conditions
Interventions
Test Group:TNP-2198 capsules, rabeprazole sodium enteric-coated tablets, amoxicillin capsules
Control Group:Amoxicillin capsules, clarithromycin tablets, rabeprazole sodium enteric-coated tablets, Bismuth potassium citrate capsules
Sponsors
Department of Gastroenterology, Peking Universsity Third Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) voluntarily sign informed consent; 2) Age 18-65 years old (including 18, 65 years old), male and female; 3) 13C-UBT results were positive (test value =4), and Helicobacter pylori infection was confirmed by gastroscopy biopsy; 4) Subjects agreed that during the screening period to the end of the study (visit 5, i.e., the efficacy evaluation visit), no antibiotics or Chinese patent medicine with antibacterial effect, bismuth, acid inhibitor (such as PPI, H2 receptor blocker, P-CAB, etc.) other than the investigational drug were allowed to take; 5) The subjects and their heterosexual partners must agree that they have no plans to become pregnant and voluntarily take effective contraceptive measures during the trial period and at least 6 months after the end of the medication; 6) Willing to follow and able to complete all test procedures.
Exclusion criteria
Exclusion criteria: 1) Allergic to test drugs (rabeprazole sodium, amoxicillin, clarithromycin, bismuth potassium citrate), allergic constitution (multiple drugs and food allergies); Or presence of any contraindications to the use of rifamycin, nitroimidazoles or investigational drugs; 2) Have a history of Helicobacter pylori eradication treatment (including participation in other clinical trials of Helicobacter pylori eradication); 3) Patients with confirmed tuberculosis and Mycobacterium avium disease or with a history of tuberculosis and Mycobacterium avium; 4) History of dysphagia or any gastrointestinal diseases that affect drug absorption; 5) History of pyloric obstruction; Or hypersecretion of gastric acid (such as Zhuo - Ai syndrome); 6) have a history of gastric cancer; 7) A history of malignant tumors within 5 years before screening, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix without evidence of recurrence after treatment; 8) History of esophageal or gastric surgery, except simple repair of perforated ulcer; 9) History of drug abuse or drug use in the 5 years before screening; 10) A history of alcohol abuse within 5 years before screening (average consumption of =14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine/yellow rice wine/rice wine); 11) Patients with active gastric and/or duodenal ulcers; 12) Need anticoagulant therapy or long-term use of non-steroidal anti-inflammatory drugs; 13) receiving any other study medication within 4 weeks prior to the screening period; 14) to receive any prohibited drug or non-drug treatment as specified in the protocol (see Section 6.3); 15) White blood cell count or neutrophil count below the lower limit of normal value; 16) Anemia (hemoglobin < 90 g/L); 17) aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TBIL) or serum creatinine exceeded the upper limit of normal range; 18) Hepatitis B surface antigen, hepatitis C antibody, AIDS antibody, treponema pallidum antibody positive; 19) ECG abnormalities have clinical significance; 20) The female subjects were pregnant or lactating during the screening period, or had a positive urine pregnancy result; 21) Unable to communicate well with the researcher and comply with the research requirements; 22) Other conditions considered by the investigator to be unsuitable for participation in the study, such as history of severe central nervous system, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urinary, endocrine or hematologic diseases, or clinical manifestations of these diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eradication Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness;Safety;Pharmacokinetic Profile; | — |
Countries
China
Contacts
Public ContactLiya Zhou
Peking Universsity Third Hospital
Outcome results
None listed