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

Primary Purpose

Rescue Therapy for Helicobacter Pylori

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
RBLF
RA
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rescue Therapy for Helicobacter Pylori focused on measuring Helicobacter pylori, rescue, quadruple therapy，dual therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Shanghai Renji Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group RBLF

Group RA

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

scale analysis of drug safety

Full Information

First Posted
February 28, 2013
Last Updated
March 5, 2013
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01805934
Brief Title
Quadruple Therapy Versus Dual Therapy as Rescue Regimens for Helicobacter Pylori Infection
Official Title
Quadruple Therapy With Furazolidone Versus Dual Therapy With High Doses of Amoxicillin as Rescue Regimens for Helicobacter Pylori Infection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rescue Therapy for Helicobacter Pylori
Keywords
Helicobacter pylori, rescue, quadruple therapy，dual therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group RBLF
Arm Type
Active Comparator
Arm Description
receive a 14-day quadruple therapy,including rabeprazole(10mg bid),bismuth citrate(220mg bid),levofloxacin(200mg qm) and furazolidone(100mg bid).
Arm Title
Group RA
Arm Type
Active Comparator
Arm Description
receive a 14-day dual therapy with high doses of rabeprazole(20mg bid) and amoxicillin(1000mg tid).
Intervention Type
Drug
Intervention Name(s)
RBLF
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
RA
Intervention Description
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).
Primary Outcome Measure Information:
Title
13C-urea breath test
Description
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 Outcome Measure Information:
Title
scale analysis of drug safety
Time Frame
4 weeks after treatment
Other Pre-specified Outcome Measures:
Title
13C-urea breath test
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiaobo Li, MD
Organizational Affiliation
RenJi Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Renji Hospital
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

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

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