helicobacter pylori (Hp) infection
Conditions
Interventions
experimental group:H008 tablets + esomeprazole magnesium enteric-coated tablet simulator +2 antibiotics (amoxicillin and clarithromycin) +1 bismuth agent (bismuth potassium citrate)
control group:Nexium +H008 tablets simulator +2 antibiotics (amoxicillin and clarithromycin) +1 bismuth agent (bismuth potassium citrate)
Sponsors
The First Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, gender unlimited; 2. During the screening visit, the subjects were determined to be Hp positive by 13C-UBT and Hp eradication therapy was required (If the subject has been confirmed positive for Hp by 13C-UBT or 14C-UBT in our hospital within 7 days prior to signing the ICF and has not started Hp eradication therapy, the test result can be used without the need to repeat the 13C-UBT test after signing the ICF); 3. Fully understand the content of the experiment, voluntarily participate in the experiment, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Known allergic history to H008 tablets or Esomeprazole, or to excipients related to H008 tablets or Esomeprazole magnesium enteric-coated tablets, such as mannitol, microcrystalline cellulose, cross-linked poveidone, hydroxypropyl cellulose, magnesium stearate, film coating agent; 2. History of hypersensitivity or allergy to amoxicillin, clarithromycin and bismuth (including any related excipients); Or have a history of severe rapid-onset hypersensitivity to other macrolides antibiotics, ß-lactam agents (such as cephalosporins, carbapenems, monocyclic ß-lactam); Skin tests can be performed according to local medical routine standards before randomization; 3. The subject has Zollinger-Ellison syndrome; 4. Subjects known to have acute upper gastrointestinal bleeding, active gastric or duodenal ulcer, acute gastric mucosal injury (AGML) or acute duodenal mucosal injury (ADML) at the time of screening; 5. Surgical procedures (e.g., abdominal surgery, vagotomy, or craniotomy) that may affect gastric acid secretion were performed 1 month before randomization and planned to be performed during the study period; 6. Subjects with a history of malignant tumors within 5 years prior to screening (subjects may participate in this study if they have been cured of basal cell carcinoma of the skin or cervical carcinoma in situ); 7. The subject has severe central nervous system, cardiovascular, respiratory, liver, kidney, gastrointestinal, urinary, endocrine or hematological diseases that the investigator believes may confuse the study results or affect the safety of the subject; 8. Laboratory examination during the screening period showed ALT or AST > 1.5 times of the upper limit of normal value, or renal function Cr > the upper limit of normal value (one review was allowed in the study, and those who still did not meet the requirements for inclusion were excluded); 9. Subjects with hypokalemia; 10. Subjects with a history of prolonged QT interval or ventricular arrhythmias (including tip torsion ventricular tachycardia) were screened for a Friderica-corrected QT interval (QTcF> 450 ms in male and 470 ms in female); 11. Previously received Helicobacter pylori eradication treatment; 12. Antibiotics, bismuth-containing preparations, or traditional Chinese medicine with antibacterial effects were used within 4 weeks before 13C-UBT test during the screening period; Used PPI or P-CAB preparations within 2 weeks before 13C-UBT examination during the screening period; 13. Subjects who were taking Azanavir sulfate and ripiavirin hydrochloride at the time of screening; 14. Subjects who required any of the following medications during the 14-day treatment period of the study: astemizole, cisapride, pimoxide, terphenadine, ticagrelor or ranozine, colchicine, lovastatin or simvastatin, midazolam, ergotamine or dihydroergotamine, methylene sulfonate, allopurinol, and methotrexate; 15. Those with chronic drug abuse or alcohol dependence in the 12 months prior to screening; 16. Female subjects who are suspected or already pregnant, breastfeeding or planning to become pregnant during the study. Women of childbearing age who, in the investigator's judgment, were unable to use a medically approved and reliable contraceptive method within 4 weeks after the final study dosing; 17. Participated in other drug/device clinical studies and used experimental drugs/devices within 3 months before randomization; 18. Others were deemed unsuitable for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hp eradication rate after 4 weeks; | — |
Countries
China
Contacts
Public ContactChen Minhu, Xiao Yinglian
Outcome results
None listed