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

NCT03342456 | Completed Phase 4

• 1 other identifier: xucanxia2000
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Helicobacter pylori eradication; Duodenal Ulcer; Ilaprazole/Doxycycline-based Bismuth-containing quadruple therapy

Outcome Measures

Primary Outcomes (1)

• The eradication rate of H. pylori infection

  Evaluated by 13C-urea breath test (13C-UBT), 14C-urea breath test (14C-UBT), or Pathological examination.

  Visit period 3 (After day 56)

Secondary Outcomes (6)

• The healing rate of duodenal ulcer(s)

  Visit period 2 (day 28±1)

• Number of duodenal ulcer(s)

  Visit period 2 (day 28±1)

• Maximum diameter of duodenal ulcer(s)

  Visit period 2 (day 28±1)

• Surrounding inflammation and(or) erosion of duodenal ulcer(s)

  Visit period 2 (day 28±1)

• Incidence of bleeding

  Visit period 2 (day 28±1)

Other Outcomes (7)

• Degree of pain

  Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)

• Degree of burning

  Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)

• Degree of acid reflux

  Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)

Study Arms (2)

group 1

EXPERIMENTAL

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

Drug: Doxycycline Hyclate Enteric-Coated Capsules; Drug: Ilaprazole Enteric-Coated Tablets; Drug: Furazolidone Tablets; Drug: Potassium Citrate Tablets

group 2

ACTIVE COMPARATOR

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

Drug: Amoxicillin Capsules; Drug: Ilaprazole Enteric-Coated Tablets; Drug: Furazolidone Tablets; Drug: Potassium Citrate Tablets

Interventions

Doxycycline Hyclate Enteric-Coated Capsules DRUG

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

group 1

Amoxicillin Capsules DRUG

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

group 2

Ilaprazole Enteric-Coated Tablets DRUG

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

group 1; group 2

Furazolidone Tablets DRUG

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

group 1; group 2

Potassium Citrate Tablets DRUG

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

group 1; group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The diameter of the ulcer is 0.3 to 2.0cm, and the number is less than or equal 2.
• Has evidence(s) of Hp infection. (13C-UBT/14C-UBT/Pathological test)
• Has a history of antiacid medication, but has been stopped for more than 2 weeks.
• Has not used antibiotics and (or) bismuth agents in nearly four weeks.
• Understand and be willing to participate in this clinical trial.

You may not qualify if:

• Has been taking ulcer medications, such as non-steroidal anti-inflammatory drugs, adrenal corticosteroids etc.
• Has allergic and idiosyncratic responses to the tested drugs and (or) control drugs.
• 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.
• Has severe or progressive dysphagia, weight loss, gastrointestinal bleeding or other alarm symptoms.
• 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.
• Has a history of gastric acid suppression surgery, esophageal surgery, or digestive organ surgery, with the exception of simple suture of perforation.
• Is pregnant, breastfeeding or has a family planning during whole trail.
• Has serious cardiovascular, pulmonary, hepatic, renal, hematological or endocrine disease with uncontrolled condition.
• Has participated in other clinical trials within 3 months prior to the trial.
• Is required to use the prescribed anti-ulcer drug during the trial.
• Has a history of drug and (or) alcohol abuse.
• Has restriction on sodium, with metabolic alkalosis and (or) hypocalcemia.
• Has a long-term use of clopidogrel.
• Has other reasons for not to participating in clinical trials.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead
• Livzon Pharmaceutical Group Inc.: collaborator
• Yung Shin Pharm. Ind. Co., Ltd.: collaborator

Study Sites (7)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

The First Affiliated Hospital of University of South China

Hengyang, Hunan, 421001, China

Location

Loudi central hospital

Loudi, Hunan, 417000, China

Location

Shaoyang Central Hospital

Shaoyang, Hunan, 422000, China

Location

The Affiliated Hospital Of YongZhou Vocational Technical College

Yongzhou, Hunan, 425000, China

Location

MeSH Terms

Conditions

Duodenal Ulcer

Interventions

Amoxicillin; Furazolidone; Potassium Citrate

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitrofurans; Nitro Compounds; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Furans; Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids

Study Officials

• JINGSHU CHI

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• XIAOMING LIU

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Professor of Department of Gastroenterology, Principal Investigator

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 17, 2017
• Study Start: December 13, 2017
• Primary Completion: June 20, 2019
• Study Completion: September 20, 2019
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)