Empirical Rescue Therapies of Helicobacter Pylori Infection

June 1, 2013 updated by: Dr. HONG LU, Shanghai Jiao Tong University School of Medicine

Helicobacter Pylori Treatment

The increase of antibiotic resistance to H. pylori causes failure of treatment. Furazolidone, amoxicillin and tetracycline are good candidates for rescue therapy since resistance to these three antimicrobials was rare. It is necessary to assess the efficacy and safety of these four bismuth-containing quadruple regimens with above antibiotics as empirical rescue therapies for H. pylori eradication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

424

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

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Renji 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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • H. pylori -positive patients with functional dyspepsia and scarred peptic ulcers who had previously failed one or more eradication regimens containing clarithromycin, metronidazole and/or amoxicillin.

Exclusion Criteria:

  • less than 18 years old, never receiving eradication treatment before, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks

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: tetracycline/furazolidone
one of the four empirical rescue therapies
Drug: Proton Pump Inhibitor
Other Names:
  • Lansoprazole
Drug: Bismuth
Other Names:
  • Bismuth potassium citrate
Drug: Tetracycline
Drug: Furazolidone
Experimental: amoxicillin/tetracycline
one of the four empirical rescue therapies
Drug: Amoxicillin
Drug: Proton Pump Inhibitor
Other Names:
  • Lansoprazole
Drug: Bismuth
Other Names:
  • Bismuth potassium citrate
Drug: Tetracycline
Experimental: amoxicillin/furazolidone
one of the four empirical rescue therapies
Drug: Amoxicillin
Drug: Proton Pump Inhibitor
Other Names:
  • Lansoprazole
Drug: Bismuth
Other Names:
  • Bismuth potassium citrate
Drug: Furazolidone
Active Comparator: tetracycline /metronidazole
Classical rescue therapy
Drug: Metronidazole
Drug: Proton Pump Inhibitor
Other Names:
  • Lansoprazole
Drug: Bismuth
Other Names:
  • Bismuth potassium citrate
Drug: Tetracycline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
eradication rate of H. pylori
Time Frame: 2 months
2 months

Collaborators and Investigators

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

Sponsor

Shanghai Jiao Tong University School of Medicine

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

July 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

August 16, 2012

First Submitted That Met QC Criteria

August 17, 2012

First Posted (Estimate)

August 20, 2012

Study Record Updates

Last Update Posted (Estimate)

June 4, 2013

Last Update Submitted That Met QC Criteria

June 1, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rjkls_2012009

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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