Helicobacter pylori
Conditions
Interventions
tegorazon combined with amoxicillin:tegorazon 50 mg bid + amoxicillin 1000 mg tid for 14 days
bismuth quadruplex therapy containing esomeprazole:Esomeprazole 20 mg + amoxicillin 1000mg + clarithromycin 500 mg+bismuth potassium citrate capsules 300mg twice a day for 14days
Sponsors
THE EIGHTH AFFILIATED HOSPITAL,SUN YAT-SEN UNIVERSITY(Shenzhen Futian)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-80 years; 2) Adult subjects who voluntarily sign a written informed consent form approved by the ethics committee to participate in this study prior to the commencement of any research procedure; 3) Subjects who can understand and comply with the protocol requirements and agree to participate in all study visits; 4) Patients who test positive for Hp and are judged by the investigator to be required for HP-eradication therapy should be patients who have eradicated Hp for the first time; 5) Subject agrees to use appropriate medical methods for contraception during the study (except for medical sterilization).
Exclusion criteria
Exclusion criteria: 1) previous eradication therapy for Helicobacter pylori; 2) Participated in other clinical studies within 4 weeks prior to screening; 3) pregnant or lactating women; 4) Known allergy to tigolaxen, esomeprazole, penicillins or other ß lactams, macrolide antibiotics or bismuth (including any related excipients). If a skin sensitivity test (skin test) is required, it is done according to medical practice; 5) Subject has a history of drug (including, but not limited to, opioid) abuse or alcohol abuse (14 units of alcohol per week, 1 unit of alcohol ˜ 360mL of beer by about 5% alcohol or 45mL of spirits containing approximately 40% alcohol or 150mL of wine containing approximately 12% alcohol in the 1 year prior to the screening visit);7) The subject has previously performed surgery or manipulation that may affect gastric acid secretion or affect drug absorption, such as major gastric resection and whole stomachExcision, vagotomy, intestinal resection, etc. Simple surgery to treat perforation, appendectomy, cholecystectomy, and Endoscopic resection of benign tumors is acceptable;8) Subjects with dysphagia, severe dysphagia, bleeding, weight loss, anemia, or blood in the stool may be suggestive of the gastrointestinal tract"Warning" symptoms of malignant lesions, unless the possibility of malignant lesions is xcluded by endoscopy;9) History of malignancy within 5 years prior to screening (allowed if the subject's basal cell carcinoma of the skin or carcinoma in situ of the cervix has been cured Xu participated in this study);10) subjects who cannot undergo upper gastrointestinal endoscopy;11) Upper gastrointestinal endoscopy showed acute upper gastrointestinal bleeding, active gastric ulcer or duodenal ulcer, and acute gastric stickiness Damage to the membrane or duodenal mucosa;12) According to the judgment of the investigator, the subject has uncontrolled and unstable liver, kidney, cardiovascular, respiratory, gastrointestinal, and internal divisions secretary, blood, central nervous system or psychiatric diseases, etc., participation in the study may affect the safety of the subject or the interpretation of the results of the study;13) subjects who plan to be hospitalized for surgery during the course of the study;14) Subject had taken an H2 receptor antagonist or PPI within 14 days prior to the screening period 13C-urea breath test; Screening period 13C- taking antibacterial drugs, bismuth, and certain traditional Chinese medicines with antibacterial effects within 28 days before the urea breath test;15) Abnormal results of any of the following laboratory tests at screening:– AST > upper limit of normal value (ULN);– ALT>ULN– Total bilirubin >ULN;– Creatinine > 1.5 times ULN;16) Subject has clinically significant abnormal electrocardiogram (ECG), including severe arrhythmia, multifocal premature ventricular contractions(PVC), second-degree and above atrioventricular block, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hp eradication rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hp eradication rates of amoxicillin and clarithromycin in different sensitive situations;intestinal microecology;comparison of incidence of adverse reactions; | — |
Countries
China
Contacts
Public Contacthonglei chen
THE EIGHTH AFFILIATED HOSPITAL,SUN YAT-SEN UNIVERSITY(Shenzhen Futian)
Outcome results
None listed