Completed

Helicobacter Pylori Treatment

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What is being tested

Proton Pump Inhibitor

+ Bismuth

+ Tetracycline

Drug
Who is being recruted

From 18 to 70 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: July 2012
See protocol details

Summary

Principal SponsorShanghai Jiao Tong University School of Medicine
Last updated: June 4, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01668927
Principal SponsorShanghai Jiao Tong University School of Medicine
Last updated: June 4, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

424 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate
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
1 exclusion criteria prevent from participating
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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
one of the four empirical rescue therapies

Group II

Experimental
one of the four empirical rescue therapies

Group III

Experimental
one of the four empirical rescue therapies

Group IV

Active Comparator
Classical rescue therapy

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Renji Hospital

Shanghai, ChinaOpen Renji Hospital in Google Maps
CompletedOne Study Center