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Efficacy of High-dose Dual Therapy vs Bismuth-containing Quadruple Therapy for First-line Treatment of Hp Infection

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ClinicalTrials.gov Identifier: NCT02483715
Recruitment Status : Recruiting
First Posted : June 29, 2015
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

Up to now, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of high-dose dual therapy (HDDT) and bismuth-containing quadruple therapy (BQT) as 1st-line regimens for H. pylori eradication.

The aims of this study are:

  1. to compare the efficacy of HDDT, and BQT as 1st-line regimen in H. pylori eradication;
  2. to compare the patient adherence and adverse effects of these treatment regimens;
  3. to investigate factors that may influence H. pylori eradication by these treatment regimens.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: High-dose dual therapy (rabeprazole, amoxicillin) Drug: Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline) Phase 4

Detailed Description:

Participants, aged ≥ 20, having H. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric ulcers) will be recruited. All undergo endoscopy with biopsy for rapid urease teat, histology, and bacterial culture before treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by the 13C-urea breath test. The CYP2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymerase (PCR-RFLP) method. A computed generated random numbers sequence will be blocked into two subgroups, say A, and B.

If the participants did not receive anti-H. pylori therapy previously, they will be invited to enter this study for evaluated the efficacy of these 1st-line regimens. Participant who meet the inclusion criteria and do not have any one of the exclusion criteria will be randomized to receive one of the following regimens:

group A- HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days);

group B- BQT ( rabeprazole 20 mg qid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days);

All participants will be asked to complete a questionnaire and to record symptoms and drug consumption daily during the treatment period. Post-treatment, the participants will be followed up at the Outpatients Clinic to investigate patient adherence and adverse effect of treatment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of High-dose Dual Therapy Versus Bismuth-containing Quadruple Therapy for First-line Treatment of Helicobacter Pylori Infection - A Prospective, Randomized, Comparative Study
Study Start Date : July 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High-dose dual therapy
group A-high-dose dual therapy ( rabeprazole 20 mg, tablet, qid + amoxicillin 750 mg, capsule, qid for 14 days)
Drug: High-dose dual therapy (rabeprazole, amoxicillin)
High-dose dual therapy ( rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days)
Other Names:
  • Proton pump inhibitor, Rabeprazole, Pariet®
  • Antibiotics, Amoxicillin ,Amoxicillin®

Active Comparator: Bismuth-containing quadruple therapy
group B-bismuth-containing quadruple therapy (rabeprazole 20 mg, tablet, bid + tripotassium dicitrate bismuthate 300 mg, tablet, qid + metronidazole 250 mg, tablet, qid + tetracycline 500 mg qid, capsule, for 10 days)
Drug: Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline)
Bismuth-containing quadruple therapy (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days)
Other Names:
  • Proton pump inhibitor, Rabeprazole, Pariet®
  • Antibiotics, Metronidazole, Flagyl®
  • Antibiotics, Tetracycline, Tetracycline®
  • Colloidal Bismuth, Tripotassium dicitrate bismuthate, KCB®




Primary Outcome Measures :
  1. The eradication rates as a measure of the efficacy of HDDT, and BQT [ Time Frame: 3.5 years ]
    The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.


Secondary Outcome Measures :
  1. Number of participants with adverse effects as a measure of safety [ Time Frame: 3.5 years ]
    The safety will be evaluated by counting the number of participant with adverse events.

  2. Amount of unused medication post treatment as a measure of patient adherence. [ Time Frame: 3.5 years ]
    The patient adherence will be evaluated by counting unused medication after the treatment.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Participants having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 20 years old and are willing to received eradication therapy.

Exclusion criteria:

  1. pregnant or nursing woman
  2. serious concomitant illness and malignant tumor of any kind
  3. history of hypersensitivity to test drugs
  4. serious bleeding during the course of the ulcer
  5. previous gastric surgery
  6. receiving bismuth salts, PPIs, or antibiotics in the previous month.

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): NCT02483715


Contacts
Contact: Jyh-Chin Yang, M.D.Ph.D. 886-2-23123456 ext 65055 jcyang47@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Jyh-Chin Yang    886-2-23123456 ext 65055    jcyang47@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jyh-Chin Yang, M.D.Ph.D. National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02483715     History of Changes
Other Study ID Numbers: 201503120MIND
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017

Keywords provided by National Taiwan University Hospital:
Helicobacter pylori
high dose dual therapy
bismuth-containing quadruple therapy
antibiotic resistance

Additional relevant MeSH terms:
Infection
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Amoxicillin
Tetracycline
Antibiotics, Antitubercular
Metronidazole
Rabeprazole
Proton Pump Inhibitors
Bismuth
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antacids
Protein Synthesis Inhibitors