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Completed

NCT Number: NCT01805934

Quadruple Therapy Versus Dual Therapy as Rescue Regimens for Helicobacter Pylori Infection

The eradication rates of first-line treatment for Helicobacter pylori(Hp) infection are not satisfactory. The study aims to compare the efficacy and safety between quadruple therapy with furazolidone and dual therapy with high doses of amoxicillin as rescue regimens for Hp.

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Key information

Conditions

Rescue Therapy for Helicobacter Pylori

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Renji Hospital

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged from 18 to 80 years, who presented with upper gastrointestinal symptoms and endoscopically proven H. pylori-positive non-ulcer dyspepsia, were recruited into the study.

Exclusion criteria

  • patients with peptic ulcer,
  • previous H. pylori eradication treatment,
  • previous gastric surgery,
  • pregnancy,
  • lactation,
  • major systemic diseases,
  • receipt of anti-secretory therapy,
  • antibiotics or bismuth in the preceding four weeks, or - allergy to any one of the medications in the regimen.

Treatment and study plan

RBLF

Drug

The patients in Group RBLF will receive a 14-day quadruple therapy,including rabeprazole(10mg bid),bismuth citrate(220mg bid),levofloxacin(200mg qm) and furazolidone(100mg bid).

RA

Drug

The patients in Group RA will be sent to a penicillin skin test before treatment except they were given penicillin before. They will receive a 14-day dual therapy with high doses of rabeprazole(20mg bid) and amoxicillin(1000mg tid).

Primary outcomes

  1. 13C-urea breath test

    Time frame: 4 weeks after treatment

    When the outcome of 13C-urea breath test is more than 4%, the helicobacter pylori infection is still exist(positive).

Secondary outcomes

  1. scale analysis of drug safety

    Time frame: 4 weeks after treatment

Other outcomes

  1. 13C-urea breath test

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Quadruple Therapy With Furazolidone Versus Dual Therapy With High Doses of Amoxicillin as Rescue Regimens for Helicobacter Pylori Infection

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Mar 6, 2013
Registry last updated
Mar 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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