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

Phase 2

Completed

• Conditions: Rescue Therapy for Helicobacter Pylori
• Interventions: Drug: RBLF; Drug: RA

• Registration Number: NCT01805934
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2012-12
• Study Completion: 2013-02
• Study First Submitted: 2013-02-28
• Status Verified: 2013-03
• Study First Submitted QC: 2013-03-05
• Last Update Submitted: 2013-03-05
• Study First Posted: 2013-03-06
• Last Update Posted: 2013-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group RBLF	RBLF	receive a 14-day quadruple therapy,including rabeprazole(10mg bid),bismuth citrate(220mg bid),levofloxacin(200mg qm) and furazolidone(100mg bid).
Group RA	RA	receive a 14-day dual therapy with high doses of rabeprazole(20mg bid) and amoxicillin(1000mg tid).

Primary Outcome Measures

Name	Time	Method
13C-urea breath test	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 Outcome Measures

Name	Time	Method
scale analysis of drug safety	4 weeks after treatment

Trial Locations

Locations (1)

Shanghai Renji Hospital; 🇨🇳 Shanghai, Shanghai, China