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Trial record 82 of 582 for:    Recruiting, Not yet recruiting, Available Studies | Superior

Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy

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ClinicalTrials.gov Identifier: NCT02894268
Recruitment Status : Recruiting
First Posted : September 9, 2016
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Weiling Hu, MD,PhD, Sir Run Run Shaw Hospital

Brief Summary:
Doxycycline- and Furazolidone-containing Quadruple Regimen can be a successful rescue treatment for Helicobacter pylori Infection patients after Failure of several therapy. It is superior of tailored therapy as rescue treatment for helicobacter pylori Infection after failure of several therapy.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Doxycycline Drug: Furazolidone Drug: Esomeprazole Drug: Colloidal Bismuth Subcitrate Drug: Sensitivity antibiotics Phase 4

Detailed Description:

This study is a prospective, multiple centers, randomized trial. Patients who had failed in previous H. pylori eradication treatment that more than two times will be enrolled in Sir Run Run Shaw Hospital.

Pretreatment H. pylori status will be defined by a positive 13 C-urea breath test (13 C-UBT). Patients who had received bismuth compounds, acid inhibitor, or antibiotics during 4 weeks before 13 C-UBT are excluded. Other exclusion criteria included upper gastrointestinal surgery, malignancy, and evidence of blood dyscrasia.

After the patient is enrolled the patient will sign the informed consent and receive gastroscopy. More than four biopsy will be given including two in antrum and two in gastric body. One pair of biopsy sample will be sent for the pathology and the other pair is used for H.pylori culture and antibiotics sensitivity. After we get the result of antibiotics sensitivity the patient will be divided randomly into two groups, Regimen A, Regimen B.

The Regimen A includes esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg . All drugs are taken twice a day for 14 days. The Regimen B includes two antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg. The esomeprazole and bismuth are taken half an hour before a meal and antibiotics after the meal.

All patients are asked to quit smoking and drinking and forbid eating foods rich in tyramine (e.g., chicken, cheese, pickles, lentils, beans) and seafood during and in 1 week after the treatment.

Patients will be followed up at the 1st day, 14th day, and 4 weeks after the treatment, respectively, and all side effects will be collected.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy as Rescue Treatment for Helicobacter Pylori Infection After Failure of Several Therapy
Actual Study Start Date : February 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Regimen A
esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg
Drug: Doxycycline
Doxycycline 100g po bid
Other Name: Vibramycin

Drug: Furazolidone
Furazolidone 100mg po bid
Other Name: Giarlan

Drug: Esomeprazole
Esomeprazole 20mg po bid
Other Name: Nexium

Drug: Colloidal Bismuth Subcitrate
Bismuth 20mg po bid
Other Name: PIDI

Active Comparator: Regimen B
two sensitivity antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg
Drug: Esomeprazole
Esomeprazole 20mg po bid
Other Name: Nexium

Drug: Colloidal Bismuth Subcitrate
Bismuth 20mg po bid
Other Name: PIDI

Drug: Sensitivity antibiotics
Two antibiotics based on antibiotic sensitivity of H.pylori culture, including amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline and furazolidone.




Primary Outcome Measures :
  1. H. pylori eradication rate [ Time Frame: 42 days after start of therapy ]
    Repeat 13-Urea breath test 42 days after H.pylori eradication


Secondary Outcome Measures :
  1. Clinical response as measured by Number of participants whose symptoms disappear or improve after eradication treatment [ Time Frame: 14 days and 42 days after H.pylori eradication ]
    Number of participants whose symptoms disappear or improve after eradication treatment.

  2. Side effects [ Time Frame: 14 days after start of therapy ]
    Adverse Events That Are Related to Eradication Treatment

  3. Adherence rate [ Time Frame: 14 days after start of therapy ]
    Number of patients who take at least 80% drugs



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

Inclusion Criteria:

  1. A positive 13 C-urea breath test
  2. Formal H.pylori treatment more than two times
  3. Age >18 years

Exclusion Criteria:

  1. Bismuth compounds, acid inhibitor, or antibiotics during 4 weeks before the patient is enrolled
  2. Allergic to the medications
  3. Upper gastrointestinal surgery history
  4. Serious heart insufficiency, liver insufficiency, renal insufficiency and other serious medical problems
  5. Evidence of blood dyscrasia
  6. Pregnant and lactating women
  7. Can't express his complain correctly and can't cooperate with the researcher

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): NCT02894268


Contacts
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Contact: Ning Dai, Chief +86138-6745-7664 2267454962@qq.com
Contact: Weiling Hu, Attending +86153-9705-9751 ringwh@163.com

Locations
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China, Zhejiang
Sir Run Run Shaw Hospital,Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Weiling Hu, Attending    +86153-9705-9751    ringwh@163.com   
Principal Investigator: Weiling Hu, Atrending         
Sponsors and Collaborators
Sir Run Run Shaw Hospital
Investigators
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Principal Investigator: Weiling Hu, Attending Sir Run Run Shaw Hospital

Publications of Results:
Other Publications:
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Responsible Party: Weiling Hu, MD,PhD, Clinical Professor, Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier: NCT02894268     History of Changes
Other Study ID Numbers: 20160513-1
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Infection
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Doxycycline
Antibiotics, Antitubercular
Furazolidone
Bismuth tripotassium dicitrate
Esomeprazole
Bismuth
Anti-Infective Agents
Antitubercular Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Antacids
Anti-Infective Agents, Local
Anti-Infective Agents, Urinary
Renal Agents
Antitrichomonal Agents
Monoamine Oxidase Inhibitors