Back to resultsThe Efficacy and Safety of Ilaprazole/Doxycycline-based Bismuth-containing Quadruple Therapy on Hp Infected Duodenal Ulcers
Primary Purpose
Duodenal Ulcer Due to Helicobacter Pylori
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Doxycycline Hyclate Enteric-Coated Capsules
Amoxicillin Capsules
Ilaprazole Enteric-Coated Tablets
Furazolidone Tablets
Potassium Citrate Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Duodenal Ulcer Due to Helicobacter Pylori focused on measuring Helicobacter pylori eradication, Duodenal Ulcer, Ilaprazole/Doxycycline-based Bismuth-containing quadruple therapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Xiangya Hospital of Central South University
- The Second Xiangya Hospital of Central South University
- The Third Xiangya Hospital of Central South University
- The First Affiliated Hospital of University of South China
- Loudi central hospital
- Shaoyang Central Hospital
- The Affiliated Hospital Of YongZhou Vocational Technical College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group 1
group 2
Arm Description
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
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
Outcomes
Primary Outcome Measures
The eradication rate of H. pylori infection
Evaluated by 13C-urea breath test (13C-UBT), 14C-urea breath test (14C-UBT), or Pathological examination.
Secondary Outcome Measures
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.
Number of duodenal ulcer(s)
Confirmed by endoscope.
Maximum diameter of duodenal ulcer(s)
Confirmed by endoscope (cm).
Surrounding inflammation and(or) erosion of duodenal ulcer(s)
Confirmed by endoscope.
Incidence of bleeding
Confirmed by endoscope.
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.).
Full Information
NCT ID
NCT03342456
First Posted
October 30, 2017
Last Updated
February 26, 2022
Sponsor
The Third Xiangya Hospital of Central South University
Collaborators
Livzon Pharmaceutical Group Inc., Yung Shin Pharm. Ind. Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03342456
Brief Title
The Efficacy and Safety of Ilaprazole/Doxycycline-based Bismuth-containing Quadruple Therapy on Hp Infected Duodenal Ulcers
Official Title
The Efficacy and Safety of Ilaprazole/Doxycycline-based Bismuth-containing Quadruple Therapy on Hp Infected Duodenal Ulcers: A Randomized, Parallel-controlled Multi-center Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 13, 2017 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
September 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Third Xiangya Hospital of Central South University
Collaborators
Livzon Pharmaceutical Group Inc., Yung Shin Pharm. Ind. Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duodenal Ulcer Due to Helicobacter Pylori
Keywords
Helicobacter pylori eradication, Duodenal Ulcer, Ilaprazole/Doxycycline-based Bismuth-containing quadruple therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Experimental
Arm Description
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
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Doxycycline Hyclate Enteric-Coated Capsules
Intervention Description
group 1,0.1g*10 capsules/box, produced by Yung Shin Pharm.Ind.(Kunshan) Co.,Ltd.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin Capsules
Intervention Description
group 2,0.5g*24 capsules/box, produced by United Laboratories（Zhuhai）
Intervention Type
Drug
Intervention Name(s)
Ilaprazole Enteric-Coated Tablets
Intervention Description
group 1 and group 2,5mg*6 capsules/box, produced by Livzon Pharmaceutical Group Inc
Intervention Type
Drug
Intervention Name(s)
Furazolidone Tablets
Intervention Description
group 1 and group 2,0.1g*100 tablets/bottle,produced by Shanxi Yunpeng Pharmaceutical co.,Ltd.
Intervention Type
Drug
Intervention Name(s)
Potassium Citrate Tablets
Intervention Description
group 1 and group 2,110mg*40 tablets/bottle,produced by Livzon Pharmaceutical Group Inc
Primary Outcome Measure Information:
Title
The eradication rate of H. pylori infection
Description
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)
Secondary Outcome Measure Information:
Title
The healing rate of duodenal ulcer(s)
Description
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)
Title
Number of duodenal ulcer(s)
Description
Confirmed by endoscope.
Time Frame
Visit period 2 (day 28±1)
Title
Maximum diameter of duodenal ulcer(s)
Description
Confirmed by endoscope (cm).
Time Frame
Visit period 2 (day 28±1)
Title
Surrounding inflammation and(or) erosion of duodenal ulcer(s)
Description
Confirmed by endoscope.
Time Frame
Visit period 2 (day 28±1)
Title
Incidence of bleeding
Description
Confirmed by endoscope.
Time Frame
Visit period 2 (day 28±1)
Title
Improvement of gastric symptoms
Description
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)
Other Pre-specified Outcome Measures:
Title
Degree of pain
Description
Evaluated by clinical symptoms scores
Pain in day 0 point: No pain. 1 point: Mild pain, do not affect daily life and work, do not have to take medicines. 2 points: Obvious pain,partly affect daily life and work, or have to take medicines. 3 points: Severe pain, must rest, taking medicine is ineffective
Pain in night 0 point: No pain. 1 point: Mild pain, do not affect daily life and work, do not have to take medicines. 2 points: Obvious pain,partly affect daily life and work, or have to take medicines. 3 points: Severe pain, must rest, taking medicine or eat is ineffective
Time Frame
Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)
Title
Degree of burning
Description
Evaluated by clinical symptoms scores
Burning in day 0 point: No burning. 1 point: Occasionally. 2 points: Frequently and duration prolonged. 3 points: Continuously, use antacid to alleviate briefly.
Burning in night 0 point: No burning. 1 point: Occasionally. 2 points: Frequently and duration prolonged. 3 points: Continuously, use antacid to alleviate briefly.
Time Frame
Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)
Title
Degree of acid reflux
Description
Evaluated by clinical symptoms scores
Acid reflux in day 0 point: No acid reflux. 1 point: Occasionally. 2 points: One to two times a day. 3 points: Several times a day.
Acid reflux in night 0 point: No acid reflux. 1 point: Occasionally. 2 points: One to two times a day. 3 points: Several times a day.
Time Frame
Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)
Title
Degree of nausea and vomiting
Description
Evaluated by clinical symptoms scores Nausea and vomiting 0 point: No nausea. 1 point: Occasionally and briefly. 2 points: Frequent nausea, vomiting. 3 points: Continuous nausea, frequent vomiting.
Time Frame
Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)
Title
Degree of belching
Description
Evaluated by clinical symptoms scores Belching 0 point: No belching. 1 point: Occasionally. 2 points: Frequently. 3 points: Continuously, and affect normal activities.
Time Frame
Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)
Title
Degree of abdominal distension
Description
Evaluated by clinical symptoms scores Abdominal distension 0 point: No abdominal distension. 1 point: Occasionally. 2 points: Obvious abdominal distension. 3 points: Severe abdominal distension, and affect normal activities.
Time Frame
Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)
Title
Symptom disappearance time
Time Frame
Visit period 1 (day 14±1), Visit period 2 (day 28±1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JINGSHU CHI
Organizational Affiliation
The Third Xiangya Hospital of Central South University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
XIAOMING LIU
Organizational Affiliation
The Third Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
The First Affiliated Hospital of University of South China
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421001
Country
China
Facility Name
Loudi central hospital
City
Loudi
State/Province
Hunan
ZIP/Postal Code
417000
Country
China
Facility Name
Shaoyang Central Hospital
City
Shaoyang
State/Province
Hunan
ZIP/Postal Code
422000
Country
China
Facility Name
The Affiliated Hospital Of YongZhou Vocational Technical College
City
Yongzhou
State/Province
Hunan
ZIP/Postal Code
425000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy and Safety of Ilaprazole/Doxycycline-based Bismuth-containing Quadruple Therapy on Hp Infected Duodenal Ulcers
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