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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ming-Cheh Chen, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT01573975
First received: April 4, 2012
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Helicobacter Pylori Infection
Drug: 5RA-5RCM
Drug: 5RA-5RCT
Drug: 10RCA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Buddhist Tzu Chi General Hospital:

Primary Outcome Measures:
  • Eradication rate [ Time Frame: 4 weeks after complete use of drug for treatment ] [ Designated as safety issue: No ]
    A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment


Enrollment: 345
Study Start Date: January 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 95 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573975

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

Publications:
Responsible Party: Ming-Cheh Chen, Principal Investigator, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT01573975     History of Changes
Other Study ID Numbers: IRB097-76
Study First Received: April 4, 2012
Last Updated: April 9, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Buddhist Tzu Chi General Hospital:
Helicobacter pylori
antibiotic resistance
sequential therapy
Taiwan

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tetracycline
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 30, 2014