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Empirical Rescue Therapies of Helicobacter Pylori Infection

Primary Purpose

Functional Dyspepsia, Scarred Peptic Ulcer

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Proton Pump Inhibitor
Bismuth
Metronidazole
Tetracycline
Furazolidone
Amoxicillin
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 Functional Dyspepsia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • H. pylori -positive patients with functional dyspepsia and scarred peptic ulcers who had previously failed one or more eradication regimens containing clarithromycin, metronidazole and/or amoxicillin.

Exclusion Criteria:

  • less than 18 years old, never receiving eradication treatment before, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks

Sites / Locations

  • Renji Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

tetracycline/furazolidone

amoxicillin/tetracycline

amoxicillin/furazolidone

tetracycline /metronidazole

Arm Description

one of the four empirical rescue therapies

one of the four empirical rescue therapies

one of the four empirical rescue therapies

Classical rescue therapy

Outcomes

Primary Outcome Measures

eradication rate of H. pylori

Secondary Outcome Measures

Full Information

First Posted
August 16, 2012
Last Updated
June 1, 2013
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01668927
Brief Title
Empirical Rescue Therapies of Helicobacter Pylori Infection
Official Title
Helicobacter Pylori Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
October 2012 (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 increase of antibiotic resistance to H. pylori causes failure of treatment. Furazolidone, amoxicillin and tetracycline are good candidates for rescue therapy since resistance to these three antimicrobials was rare. It is necessary to assess the efficacy and safety of these four bismuth-containing quadruple regimens with above antibiotics as empirical rescue therapies for H. pylori eradication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia, Scarred Peptic Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
424 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tetracycline/furazolidone
Arm Type
Experimental
Arm Description
one of the four empirical rescue therapies
Arm Title
amoxicillin/tetracycline
Arm Type
Experimental
Arm Description
one of the four empirical rescue therapies
Arm Title
amoxicillin/furazolidone
Arm Type
Experimental
Arm Description
one of the four empirical rescue therapies
Arm Title
tetracycline /metronidazole
Arm Type
Active Comparator
Arm Description
Classical rescue therapy
Intervention Type
Drug
Intervention Name(s)
Proton Pump Inhibitor
Other Intervention Name(s)
Lansoprazole
Intervention Type
Drug
Intervention Name(s)
Bismuth
Other Intervention Name(s)
Bismuth potassium citrate
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Type
Drug
Intervention Name(s)
Tetracycline
Intervention Type
Drug
Intervention Name(s)
Furazolidone
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Primary Outcome Measure Information:
Title
eradication rate of H. pylori
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: H. pylori -positive patients with functional dyspepsia and scarred peptic ulcers who had previously failed one or more eradication regimens containing clarithromycin, metronidazole and/or amoxicillin. Exclusion Criteria: less than 18 years old, never receiving eradication treatment before, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23376004
Citation
Liang X, Xu X, Zheng Q, Zhang W, Sun Q, Liu W, Xiao S, Lu H. Efficacy of bismuth-containing quadruple therapies for clarithromycin-, metronidazole-, and fluoroquinolone-resistant Helicobacter pylori infections in a prospective study. Clin Gastroenterol Hepatol. 2013 Jul;11(7):802-7.e1. doi: 10.1016/j.cgh.2013.01.008. Epub 2013 Jan 29.
Results Reference
derived

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Empirical Rescue Therapies of Helicobacter Pylori Infection

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