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Trial record 20 of 38 for:    "Bacterial Infectious Disease" | "Rabeprazole"

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

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ClinicalTrials.gov Identifier: NCT01805934
Recruitment Status : Completed
First Posted : March 6, 2013
Last Update Posted : March 6, 2013
Sponsor:
Information provided by (Responsible Party):
Xiaobo Li, 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.

Condition or disease Intervention/treatment Phase
Rescue Therapy for Helicobacter Pylori Drug: RBLF Drug: RA Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Quadruple Therapy With Furazolidone Versus Dual Therapy With High Doses of Amoxicillin as Rescue Regimens for Helicobacter Pylori Infection
Study Start Date : May 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. 13C-urea breath test [ Time Frame: 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 :
  1. scale analysis of drug safety [ Time Frame: 4 weeks after treatment ]

Other Outcome Measures:
  1. 13C-urea breath test [ Time Frame: baseline ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805934


Locations
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China, Shanghai
Shanghai Renji Hospital
Shanghai, Shanghai, China
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Study Director: xiaobo Li, MD RenJi Hospital

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Responsible Party: Xiaobo Li, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01805934     History of Changes
Other Study ID Numbers: rjyyxhk2013-01
First Posted: March 6, 2013    Key Record Dates
Last Update Posted: March 6, 2013
Last Verified: March 2013

Keywords provided by Xiaobo Li, Shanghai Jiao Tong University School of Medicine:
Helicobacter pylori, rescue, quadruple therapy,dual therapy

Additional relevant MeSH terms:
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Gram-Negative Bacterial Infections
Bacterial Infections
Rabeprazole
Helicobacter Infections
Amoxicillin
Furazolidone
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents, Urinary
Renal Agents
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents
Monoamine Oxidase Inhibitors