The Efficacy and Safety of Ilaprazole/Doxycycline-based Bismuth-containing Quadruple Therapy on Hp Infected Duodenal Ulcers
Status:
Completed
Trial end date:
2019-09-20
Target enrollment:
Participant gender:
Summary
Helicobacter pylori (Hp) infection is one of the important causes of gastrointestinal
diseases, including gastritis, peptic ulcer, and malignancies, nd the eradication of Hp can
effectively cure or prevent these diseases. Now, owing to the increasingly serious antibiotic
resistance, Hp eradication rate is, however, becoming decreased. In order to improve the
eradication rate of Hp, clinicians pay great attention to choose more effective treatment.
Ilaprazole Enteric-Coated Tablets is a new generation of proton pump inhibitor (PPI).
Previous research found that Ilaprazole had a more prolonged half-life and higher suppression
of gastric acid secretion. In addition, its metabolism is not significantly influenced by
CYP2C19, compared to the available PPIs. Doxycycline is in the tetracycline antibiotic class,
has a stronger antibacterial force than tetracycline and its antibacterial spectrum is
basically the same as tetracycline and doxycycline, so far, it is not widely used.
Preliminary observations showed that Ilaprazole/Doxycycline-based quadruple therapy was
effective in treating Hp infection, with less adverse reactions and good compliance with
patients.
In this study, a multi-center, randomized, parallel controlled trial will be conducted in 7
hospitals in Hunan Province, China, to observe the clinical efficacy and safety of the
Bismuth-containing quadruple therapy with Ilaprazole, Doxycycline, Furazolidone and Bismuth
Potassium Citrate in the treatment of Hp infected duodenal ulcer. It is expected to complete
200 effective cases, including 100 cases in the experimental group and 100 cases in the
control group.
Phase:
Phase 4
Details
Lead Sponsor:
The Third Xiangya Hospital of Central South University
Collaborators:
Livzon Pharmaceutical Group Inc. Yung Shin Pharm. Ind. Co., Ltd.