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

April 9, 2012 updated by: Ming-Cheh Chen, Buddhist Tzu Chi General Hospital

Comparison Between Ten Days Sequential Treatment (With Metronidazole or Tetracycline) and Ten Days Standard Triple Therapy of Helicobacter Pylori

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

345

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Hualien, Taiwan, 97002
        • Buddhist Tzu Chi General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Hiconcil x 10 days.
  • Pariet x 10 days
  • Klaricid x 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks after complete use of drug for treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Buddhist Tzu Chi General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 4, 2012

First Submitted That Met QC Criteria

April 9, 2012

First Posted (Estimate)

April 10, 2012

Study Record Updates

Last Update Posted (Estimate)

April 10, 2012

Last Update Submitted That Met QC Criteria

April 9, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB097-76

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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