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Comparison Between Ten Days Sequential Treatment and Traditional Three Combined Treatment of Helicobacter Pylori

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ClinicalTrials.gov Identifier: NCT01573975
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : April 10, 2012
Sponsor:
Information provided by (Responsible Party):
Ming-Cheh Chen, Buddhist Tzu Chi General Hospital

Study Description
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Brief Summary:
The purpose of this study is to compare the eradication efficacy of 10-day triple therapy with 10-day sequential therapy with tetracycline or metronidazole.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: 5RA-5RCM Drug: 5RA-5RCT Drug: 10RCA Phase 4

Detailed Description:

Background: Antimicrobial resistance has decreased eradication rates for Helicobacter pylori infection worldwide.

Objective: To determine whether sequential treatment eradicates H. pylori infection better than standard triple-drug therapy for adults with dyspepsia or peptic ulcers in Taiwanese people.

Design: Randomized, single-blind, prospective controlled trial. Setting: A large tertiary referral hospital in eastern Taiwan. Patients: 450 patients with dyspepsia or peptic ulcers and infected by H. pylori.

Measurements: 13C-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, assessment of antibiotic resistance and CYP2C19 genotype of host.

Intervention: 450 patients with H. pylori infection are randomly assigned to receive one of the following therapeutic schemes: group A (5RA5RCT): rabeprazole (20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin (500 mg bid) and tetracycline (1g bid) for a further 5 days; group B (5RA5RCM): rabeprazole (20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin (500 mg bid) and metronidazole (500mg bid) for a further 5 days; group C as control: rabeprazole (20 mg bid) plus amoxicillin (1 g bid) and clarithromycin (500 mg bid.) for 10 days.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Ten Days Sequential Treatment (With Metronidazole or Tetracycline) and Ten Days Standard Triple Therapy of Helicobacter Pylori
Study Start Date : January 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Seq-Metronidazole
10-day sequential therapy with metronidazole
 Drug: 5RA-5RCM
rabeprazole 20mg b.i.d + amoxicillin 1000mg b.i.d x 5 days + rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + metronidazole 500mg b.i.d x last 5 days.
Other Names:
  • Pariet x 10 days
  • Hiconcil x 1st 5 days then
  • Klaricid x last 5 days +
  • Flagyl x last 5 days
Experimental: Seq-Tetracycline
10-day sequential therapy with tetracycline.
 Drug: 5RA-5RCT
rabeprazole 20mg b.i.d + amoxicillin 1000mg b.i.d x 5 days + rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + tetracycline 1000mg b.i.d x last 5 days.
Other Names:
  • Pariet x 10 days
  • Hiconcil x 1st 5 days then
  • Klaricid x last 5 days +
  • Acromycin x last 5 days.
Active Comparator: Control
10-day standard triple therapy.
 Drug: 10RCA
rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d x 10 days.
Other Names:
  • Pariet x 10 days
  • Klaricid x 10 days
  • Hiconcil x 10 days.


Outcome Measures
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Primary Outcome Measures :
  1. Eradication rate [ Time Frame: 4 weeks after complete use of drug for treatment ]
    A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient proved with infection of H. pylori in gastric mucosa
  • adult with signed inform consent

Exclusion Criteria:

  • woman in breast feeding or pregnancy.
  • allergy to drugs used in study.
  • three months without use of any antibiotic agents.
  • patients under 20 years old.
Contacts and Locations
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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): NCT01573975


Locations
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Taiwan
Buddhist Tzu Chi General Hospital
Hualien, Taiwan, 97002
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
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Principal Investigator: Ming-Cheh CHEN, MD Buddhist Tzu Chi General Hospital
More Information
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Publications:

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Responsible Party: Ming-Cheh Chen, Principal Investigator, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT01573975    
Other Study ID Numbers: IRB097-76
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012
Keywords provided by Ming-Cheh Chen, Buddhist Tzu Chi General Hospital:
Helicobacter pylori
antibiotic resistance
sequential therapy
Taiwan
Additional relevant MeSH terms:
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Clarithromycin
Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors