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
1 other identifier
interventional
114
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 28, 2013
CompletedFirst Posted
Study publicly available on registry
March 6, 2013
CompletedMarch 6, 2013
March 1, 2013
7 months
February 28, 2013
March 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
scale analysis of drug safety
4 weeks after treatment
Other Outcomes (1)
13C-urea breath test
baseline
Study Arms (2)
Group RBLF
ACTIVE COMPARATORreceive a 14-day quadruple therapy,including rabeprazole(10mg bid),bismuth citrate(220mg bid),levofloxacin(200mg qm) and furazolidone(100mg bid).
Group RA
ACTIVE COMPARATORreceive a 14-day dual therapy with high doses of rabeprazole(20mg bid) and amoxicillin(1000mg tid).
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Renji Hospital
Shanghai, Shanghai Municipality, China
Study Officials
- STUDY DIRECTOR
xiaobo Li, MD
RenJi Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Xiaobo Li
Study Record Dates
First Submitted
February 28, 2013
First Posted
March 6, 2013
Study Start
May 1, 2012
Primary Completion
December 1, 2012
Study Completion
February 1, 2013
Last Updated
March 6, 2013
Record last verified: 2013-03