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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-13

Study Completion Date

2019-09-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Duodenal Ulcer Due to Helicobacter Pylori

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group 1

week1 to week2：Doxycycline Hyclate Enteric-Coated Capsules 0.1g,orally,twice daily,taken with meals, Ilaprazole Enteric-Coated Tablets 5mg,orally,twice daily, Furazolidone Tablets 0.1g,orally,twice daily,taken with meals, Bismuth Potassium Citrate Tablets 220mg,orally,twice daily week3 to week4：Ilaprazole Enteric-Coated Tablets 5mg,orally,once daily

Group Type EXPERIMENTAL

Doxycycline Hyclate Enteric-Coated Capsules

Intervention Type DRUG

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

Ilaprazole Enteric-Coated Tablets

Intervention Type DRUG

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

Furazolidone Tablets

Intervention Type DRUG

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

Potassium Citrate Tablets

Intervention Type DRUG

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

group 2

Amoxicillin Capsules 1g,orally,twice daily,taken with meals, Ilaprazole Enteric-Coated Tablets 5mg,orally,twice daily, Furazolidone Tablets 0.1g,orally,twice daily,taken with meals, Bismuth Potassium Citrate Tablets 220mg,orally,twice daily.

week3 to week4：Ilaprazole Enteric-Coated Tablets 5mg,orally,once daily

Group Type ACTIVE_COMPARATOR

Amoxicillin Capsules

Intervention Type DRUG

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

Ilaprazole Enteric-Coated Tablets

Intervention Type DRUG

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

Furazolidone Tablets

Intervention Type DRUG

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

Potassium Citrate Tablets

Intervention Type DRUG

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

Interventions

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Doxycycline Hyclate Enteric-Coated Capsules

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

Intervention Type DRUG

Amoxicillin Capsules

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

Intervention Type DRUG

Ilaprazole Enteric-Coated Tablets

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

Intervention Type DRUG

Furazolidone Tablets

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

Intervention Type DRUG

Potassium Citrate Tablets

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Has endoscopic evidence of active duodenal ulcer(within a week before participate), accompanying or not accompanied with abdominal pain/abdominal discomfort, acid, heartburn, abdominal distention, belching and other corresponding symptoms.
2. The diameter of the ulcer is 0.3 to 2.0cm, and the number is less than or equal 2.
3. Has evidence(s) of Hp infection. (13C-UBT/14C-UBT/Pathological test)
4. Has a history of antiacid medication, but has been stopped for more than 2 weeks.
5. Has not used antibiotics and (or) bismuth agents in nearly four weeks.
6. Understand and be willing to participate in this clinical trial.

Exclusion Criteria

1. Has been taking ulcer medications, such as non-steroidal anti-inflammatory drugs, adrenal corticosteroids etc.
2. Has allergic and idiosyncratic responses to the tested drugs and (or) control drugs.
3. Has a diagnosis of duodenal carcinelcosis or a duodenal ulcer can not rule out the the possibility of malignancy (patients with gastrointestinal mucosal epithelial mild atypical hyperplasia are not ruled out) or compound ulcers.
4. Has severe or progressive dysphagia, weight loss, gastrointestinal bleeding or other alarm symptoms.
5. Has esophageal or gastric varices, Zollinger-Ellison syndrome, or serious complications such as pyloric obstruction, active bleeding in the endoscope; esophageal erosion or ulcers, other digestive serious diseases, Such as Crohn's disease, ulcerative colitis.
6. Has a history of gastric acid suppression surgery, esophageal surgery, or digestive organ surgery, with the exception of simple suture of perforation.
7. Is pregnant, breastfeeding or has a family planning during whole trail.
8. Has serious cardiovascular, pulmonary, hepatic, renal, hematological or endocrine disease with uncontrolled condition.
9. Has participated in other clinical trials within 3 months prior to the trial.
10. Is required to use the prescribed anti-ulcer drug during the trial.
11. Has a history of drug and (or) alcohol abuse.
12. Has restriction on sodium, with metabolic alkalosis and (or) hypocalcemia.
13. Has a long-term use of clopidogrel.
14. Has other reasons for not to participating in clinical trials.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No