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

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ClinicalTrials.gov Identifier: NCT03342456
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : October 9, 2018
Sponsor:
Collaborators:
Livzon Pharmaceutical Group Inc.
Yung Shin Pharm. Ind. Co., Ltd.
Information provided by (Responsible Party):
XU CANXIA, The Third Xiangya Hospital of Central South University

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 10 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 240 effective cases, including 120 cases in the experimental group and 120 cases in the control group.


Condition or disease Intervention/treatment Phase
Duodenal Ulcer Due to Helicobacter Pylori Drug: Doxycycline Hyclate Enteric-Coated Capsules Drug: Amoxicillin Capsules Drug: Ilaprazole Enteric-Coated Tablets Drug: Furazolidone Tablets Drug: Potassium Citrate Tablets Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 13, 2017
Estimated Primary Completion Date : March 20, 2019
Estimated Study Completion Date : March 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Experimental: 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
Drug: Doxycycline Hyclate Enteric-Coated Capsules
group 1,0.1g*10 capsules/box, produced by Yung Shin Pharm.Ind.(Kunshan) Co.,Ltd.

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

Active Comparator: 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

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




Primary Outcome Measures :
  1. The eradication rate of H. pylori infection [ Time Frame: Visit period 3 (After day 56) ]
    Evaluated by 13C-urea breath test (13C-UBT), 14C-urea breath test (14C-UBT), or Pathological examination.


Secondary Outcome Measures :
  1. The healing rate of duodenal ulcer(s) [ Time Frame: Visit period 2 (day 28±1) ]
    Duodenal ulcer healing rate is defined as the percentage of participants with complete healing of ulcer (according to Sakita-Fukutomi classification) under endoscope.

  2. Number of duodenal ulcer(s) [ Time Frame: Visit period 2 (day 28±1) ]
    Confirmed by endoscope.

  3. Maximum diameter of duodenal ulcer(s) [ Time Frame: Visit period 2 (day 28±1) ]
    Confirmed by endoscope (cm).

  4. Surrounding inflammation and(or) erosion of duodenal ulcer(s) [ Time Frame: Visit period 2 (day 28±1) ]
    Confirmed by endoscope.

  5. Incidence of bleeding [ Time Frame: Visit period 2 (day 28±1) ]
    Confirmed by endoscope.

  6. Improvement of gastric symptoms [ Time Frame: Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1) ]
    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.).


Other Outcome Measures:
  1. Degree of pain [ Time Frame: Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1) ]

    Evaluated by clinical symptoms scores

    1. 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
    2. 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

  2. Degree of burning [ Time Frame: Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1) ]

    Evaluated by clinical symptoms scores

    1. Burning in day 0 point: No burning. 1 point: Occasionally. 2 points: Frequently and duration prolonged. 3 points: Continuously, use antacid to alleviate briefly.
    2. Burning in night 0 point: No burning. 1 point: Occasionally. 2 points: Frequently and duration prolonged. 3 points: Continuously, use antacid to alleviate briefly.

  3. Degree of acid reflux [ Time Frame: Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1) ]

    Evaluated by clinical symptoms scores

    1. 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.
    2. 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.

  4. Degree of nausea and vomiting [ Time Frame: Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1) ]
    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.

  5. Degree of belching [ Time Frame: Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1) ]
    Evaluated by clinical symptoms scores Belching 0 point: No belching. 1 point: Occasionally. 2 points: Frequently. 3 points: Continuously, and affect normal activities.

  6. Degree of abdominal distension [ Time Frame: Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1) ]
    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.

  7. Symptom disappearance time [ Time Frame: Visit period 1 (day 14±1), Visit period 2 (day 28±1) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342456


Contacts
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Contact: CANXIA XU +8613786176248 xucanxia@163.com

Locations
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China, Hunan
Hunan Provincial People's Hospital Recruiting
Changsha, Hunan, China, 410002
Contact: JIANGTAO LIAO    +8613574899399    jt99399@163.com   
Changsha Central Hospital Not yet recruiting
Changsha, Hunan, China, 410004
Contact: YA ZENG    +8613637403676      
The First Hospital of Changsha City Not yet recruiting
Changsha, Hunan, China, 410005
Contact: LI LIU    +8613975119635      
Xiangya Hospital of Central South University Not yet recruiting
Changsha, Hunan, China, 410008
Contact: MEIHUA XU    +8613787270539    meihuaxu2001@yahoo.com.cn   
The Second Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410011
Contact: CHUNLIAN WANG    +8613973161116      
The Third Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410013
Contact: CANXIA XU    +8613786176248    xucanxia@163.com   
The First Affiliated Hospital of University of South China Not yet recruiting
Hengyang, Hunan, China, 421001
Contact: AIJUN LIAO    +8613973400930    liaoaj163@163.com   
Loudi central hospital Recruiting
Loudi, Hunan, China, 417000
Contact: FENGQIAN SONG    +8615873890651      
Shaoyang Central Hospital Recruiting
Shaoyang, Hunan, China, 422000
Contact: CHAOMIN LI    +8613762857236      
The Affiliated Hospital Of YongZhou Vocational Technical College Recruiting
Yongzhou, Hunan, China, 425000
Contact: MING YANG    +8613974621123      
Sponsors and Collaborators
The Third Xiangya Hospital of Central South University
Livzon Pharmaceutical Group Inc.
Yung Shin Pharm. Ind. Co., Ltd.
Investigators
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Principal Investigator: JINGSHU CHI The Third Xiangya Hospital of Central South University
Principal Investigator: XIAOMING LIU The Third Xiangya Hospital of Central South University

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Responsible Party: XU CANXIA, Director, Clinical Professor of Department of Gastroenterology, Principal Investigator, The Third Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03342456     History of Changes
Other Study ID Numbers: xucanxia2000
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by XU CANXIA, The Third Xiangya Hospital of Central South University:
Helicobacter pylori eradication
Duodenal Ulcer
Ilaprazole/Doxycycline-based Bismuth-containing quadruple therapy

Additional relevant MeSH terms:
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Ulcer
Duodenal Ulcer
Pathologic Processes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Citric Acid
Sodium Citrate
Amoxicillin
Doxycycline
Furazolidone
Bismuth
Potassium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Antacids
Gastrointestinal Agents
Diuretics
Natriuretic Agents