The Efficacy and Safety of Ilaprazole/Doxycycline-based Bismuth-containing Quadruple Therapy on Hp Infected Duodenal Ulcers

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.

Conditions

• Duodenal Ulcer Due to Helicobacter Pylori

Interventions

DRUG

Doxycycline Hyclate Enteric-Coated Capsules

group 1,0.1g\*10 capsules/box, produced by Yung Shin Pharm.Ind.(Kunshan) Co.,Ltd.

DRUG

Amoxicillin Capsules

group 2,0.5g\*24 capsules/box, produced by United Laboratories（Zhuhai）

DRUG

Ilaprazole Enteric-Coated Tablets

group 1 and group 2,5mg\*6 capsules/box, produced by Livzon Pharmaceutical Group Inc

DRUG

Furazolidone Tablets

group 1 and group 2,0.1g\*100 tablets/bottle,produced by Shanxi Yunpeng Pharmaceutical co.,Ltd.

DRUG

Potassium Citrate Tablets

group 1 and group 2,110mg\*40 tablets/bottle,produced by Livzon Pharmaceutical Group Inc

Sponsors & Collaborators

• Livzon Pharmaceutical Group Inc.

  collaborator INDUSTRY

• Yung Shin Pharm. Ind. Co., Ltd.

  collaborator INDUSTRY

• The Third Xiangya Hospital of Central South University

  lead OTHER

Principal Investigators

• JINGSHU CHI · The Third Xiangya Hospital of Central South University

• XIAOMING LIU · The Third Xiangya Hospital of Central South University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-13

Primary Completion

2019-06-20

Completion

2019-09-20

Countries

• China

Study Locations