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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
184
group 1,0.1g\*10 capsules/box, produced by Yung Shin Pharm.Ind.(Kunshan) Co.,Ltd.
group 2,0.5g\*24 capsules/box, produced by United Laboratories(Zhuhai)
group 1 and group 2,5mg\*6 capsules/box, produced by Livzon Pharmaceutical Group Inc
group 1 and group 2,0.1g\*100 tablets/bottle,produced by Shanxi Yunpeng Pharmaceutical co.,Ltd.
group 1 and group 2,110mg\*40 tablets/bottle,produced by Livzon Pharmaceutical Group Inc
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
Loudi central hospital
Loudi, Hunan, China
Shaoyang Central Hospital
Shaoyang, Hunan, China
The Affiliated Hospital Of YongZhou Vocational Technical College
Yongzhou, Hunan, China
The eradication rate of H. pylori infection
Evaluated by 13C-urea breath test (13C-UBT), 14C-urea breath test (14C-UBT), or Pathological examination.
Time frame: Visit period 3 (After day 56)
The healing rate of duodenal ulcer(s)
Duodenal ulcer healing rate is defined as the percentage of participants with complete healing of ulcer (according to Sakita-Fukutomi classification) under endoscope.
Time frame: Visit period 2 (day 28±1)
Number of duodenal ulcer(s)
Confirmed by endoscope.
Time frame: Visit period 2 (day 28±1)
Maximum diameter of duodenal ulcer(s)
Confirmed by endoscope (cm).
Time frame: Visit period 2 (day 28±1)
Surrounding inflammation and(or) erosion of duodenal ulcer(s)
Confirmed by endoscope.
Time frame: Visit period 2 (day 28±1)
Incidence of bleeding
Confirmed by endoscope.
Time frame: Visit period 2 (day 28±1)
Improvement of gastric symptoms
Improvement is defined as the total change from baseline symptoms scores of Symptom Rating Scale(Includidng 9 items: Pain in day, Pain in night, Burning in day, Burning in night, Acid reflux in day, Acid reflux in night, Nausea and vomiting, Belching, Abdominal distension. Depending on severity and frequency, scale ranges from 0-3 points.).
Time frame: Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)
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