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

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.

Study Overview

• Status: Completed
• Conditions: Rescue Therapy for Helicobacter Pylori
• Intervention / Treatment: Drug: RBLF; Drug: RA

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Renji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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).
Active Comparator: Group RA; receive a 14-day dual therapy with high doses of rabeprazole(20mg bid) and amoxicillin(1000mg tid).	Drug: RA; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
13C-urea breath test	When the outcome of 13C-urea breath test is more than 4%, the helicobacter pylori infection is still exist(positive).	4 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
scale analysis of drug safety	4 weeks after treatment

Other Outcome Measures

Outcome Measure	Time Frame
13C-urea breath test	baseline

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Study Director: xiaobo Li, MD, Renji Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: February 28, 2013
• First Submitted That Met QC Criteria: March 5, 2013
• First Posted (Estimate): March 6, 2013

Study Record Updates

• Last Update Posted (Estimate): March 6, 2013
• Last Update Submitted That Met QC Criteria: March 5, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Helicobacter pylori, rescue, quadruple therapy，dual therapy
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: rjyyxhk2013-01