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

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 2

Conditions: Rescue Therapy for Helicobacter Pylori

Treatments: Drug: RBLF; Drug: RA

Study type: Interventional

Funder types: Other

Identifiers

NCT01805934

rjyyxhk2013-01

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 2 patient groups

Group RBLF

Active Comparator group

Description:

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

Treatment:

Drug: RBLF

Group RA

Active Comparator group

Description:

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

Treatment:

Drug: RA