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CompletedNCT01805934Updated Mar 6, 2013

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

A Phase 2 interventional study of RBLF and RA in Rescue Therapy for Helicobacter Pylori, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-06.

Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Rescue Therapy for Helicobacter Pylori

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Keywords

  • Helicobacter pylori, rescue, quadruple therapy,dual therapy
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 114 is close to the median of 120 across 4,200 interventional studies indexed under Infections.

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Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
114 participants (actual)

Study arms

  • Active comparator
    Group RBLF

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

    Drug: RBLF

  • Active comparator
    Group RA

    receive a 14-day dual therapy with high doses of rabeprazole(20mg bid) and amoxicillin(1000mg tid).

    Drug: RA

Interventions

  • DrugRBLF

    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).

  • DrugRA

    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).

06

What researchers measure

Primary outcomes

  1. 13C-urea breath test

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

    Time frame: 4 weeks after treatment

Secondary outcomes

  1. scale analysis of drug safety

    Time frame: 4 weeks after treatment

Other outcomes

  1. 13C-urea breath test

    Time frame: baseline

07

Study locations

1 site
  • Shanghai Renji Hospital
    Shanghai, Shanghai, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01805934
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Responsible party
Xiaobo Li (Xiaobo Li, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Mar 6, 2013
Start date
May 2012
Primary completion
Dec 2012
Completion
Feb 2013
Last update
Mar 6, 2013

Study contacts

xiaobo Li, MD
study director · RenJi Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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