Quadruple Versus Sequential Therapy for Helicobacter Pylori Eradication

January 2, 2013 updated by: Dr Ivan FN Hung, The University of Hong Kong

Ten Days Quadruple Versus Sequential Therapy as Empirical First and Second Line Treatment for Helicobacter Pylori Eradication: a Randomized Crossover Trial

Helicobacter pylori (HP), a bacterium present in many people's stomachs, is one of the major causes of ulcers and cancers. Up to 20% of patients infected with H. pylori may develop peptic ulcers. However, failure rate is rising due to multiple resistant H. pylori infection. The eradication rate of first line clarithromycin based therapy has fallen to below 80%. Both quadruple and sequential treatment regime has been proposed as the first-line empirical regime. Nevertheless, comparison in terms of efficacy and side effects between the two regime remained unknown. The aim of this clinical trial is to compare the efficacy and tolerability of H. pylori eradication with a 10-day quadruple therapy versus sequential therapy as empirical first and second line treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Helicobacter pylori (HP), a bacterium present in many people's stomachs, is one of the major causes of ulcers and cancers. Up to 20% of patients infected with HP may develop peptic ulcers. However, failure rate is rising due to multiple resistant HP infection. The eradication rate of first line clarithromycin based therapy has fell to below 80% and increasing number of patients also failed the second line quadruple therapy. The aim of this clinical trial is to compare the efficacy and tolerability of H. pylori eradication with a 10-day quadruple therapy versus sequential therapy as empirical first and second line treatment.

Methods: Eligible H. pylori positive patients were randomized to receive either QUAD (esomeprazole 20mg twice daily, bismuth subcitrate 120mg four times daily, tetracycline 500mg four times daily and metronidazole 400mg four times daily) for 10 days or SEQ (esomeprazole 20mg twice daily for 10 days, amoxicillin 1g twice daily for first 5 days, clarithromycin 500mg twice daily and metronidazole 400mg four time daily for the subsequent 5 days). All patients returned 8 weeks after completing the treatment for a Urea Breath Test (UBT) to confirm eradication. Patients who failed their respective therapy were crossover to receive the alternative regimen.

Study Type

Interventional

Enrollment (Actual)

391

Phase

  • Not Applicable

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

  • Hong Kong
      • Hong Kong SAR, Hong Kong
        • The University of Hong Kong, Queen Mary 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with age 18 or above, diagnosed to have gastric HP infection

Exclusion Criteria:

  • Patients with age less than 18, with past allergy to the study medications, concurrent critical illnesses, a history of previous upper gastrointestinal surgery, intake of nonsteroidal anti-inflammatory drugs, antibiotics, probiotics, bismuth preparation, proton pump inhibitors, anticoagulants or steroids in the previous one month, pregnant or breast-feeding women, drug abusers or alcoholic, history of previous H. Pylori treatment

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequential therapy
Esomeprazole 20mg bid for 10 days, amoxicillin 1g bid for first 5 days, clarithromycin 500mg bid for last 5 days and metronidazole 400mg qid for last 5 days
Drug: Sequential therapy
Esomeprazole 20mg bid for 10 days, amoxicillin 1g bid for first 5 days, clarithromycin 500mg bid for last 5 days and metronidazole 400mg qid for last 5 days
Other Names:
  • Esomeprazole (Nexium) 20mg bid for 10 days
  • Amoxicillin 1g bid for first 5 days
  • Clarithromycin (Klacid) 500mg bid for last 5 days
  • Metronidazole (Flagyl) 400mg qid for last 5 days
Drug: Quadruple therapy
Esomeprazole 20mg bid, metronidazole 400mg qid, bismuth sub citrate 120mg qid and tetracycline 500mg qid, all for 10 days
Other Names:
  • Esomeprazole (Nexium) 20mg bid
  • Metronidazole (Flagyl) 400mg qid
  • Bismuth subcitrate 120mg qid
  • Tetracycline 500mg qid
  • all for 10 days
Active Comparator: Quadruple therapy
Esomeprazole 20mg bid, metronidazole 400mg aid, bismuth sub citrate 120mg aid and tetracycline 500mg qid, all for 10 days
Drug: Sequential therapy
Esomeprazole 20mg bid for 10 days, amoxicillin 1g bid for first 5 days, clarithromycin 500mg bid for last 5 days and metronidazole 400mg qid for last 5 days
Other Names:
  • Esomeprazole (Nexium) 20mg bid for 10 days
  • Amoxicillin 1g bid for first 5 days
  • Clarithromycin (Klacid) 500mg bid for last 5 days
  • Metronidazole (Flagyl) 400mg qid for last 5 days
Drug: Quadruple therapy
Esomeprazole 20mg bid, metronidazole 400mg qid, bismuth sub citrate 120mg qid and tetracycline 500mg qid, all for 10 days
Other Names:
  • Esomeprazole (Nexium) 20mg bid
  • Metronidazole (Flagyl) 400mg qid
  • Bismuth subcitrate 120mg qid
  • Tetracycline 500mg qid
  • all for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Helicobacter pylori eradication rate
Time Frame: 8 weeks after treatment
Percentage of patients successfully eradicated Helicobacter pylori infection confirmed by urea breath test
8 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of side effects
Time Frame: 10 days
Patients to document side effects during treatment
10 days

Collaborators and Investigators

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

Sponsor

The University of Hong Kong

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

May 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

December 29, 2012

First Submitted That Met QC Criteria

January 2, 2013

First Posted (Estimate)

January 4, 2013

Study Record Updates

Last Update Posted (Estimate)

January 4, 2013

Last Update Submitted That Met QC Criteria

January 2, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 11-221

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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