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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01805934
Enrollment
114
Registered
2013-03-06
Start date
2012-05-31
Completion date
2013-02-28
Last updated
2013-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rescue Therapy for Helicobacter Pylori

Keywords

Helicobacter pylori, rescue, quadruple therapy,dual therapy

Brief 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.

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).

Sponsors

Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
13C-urea breath test4 weeks after treatmentWhen the outcome of 13C-urea breath test is more than 4%, the helicobacter pylori infection is still exist(positive).

Secondary

MeasureTime frame
scale analysis of drug safety4 weeks after treatment

Other

MeasureTime frame
13C-urea breath testbaseline

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026