CClinicalTrials.gg
CompletedNCT01668927Updated Jun 4, 2013

Empirical Rescue Therapies of Helicobacter Pylori Infection

A Phase 4 interventional study of Proton Pump Inhibitor and Bismuth in Functional Dyspepsia and Scarred Peptic Ulcer, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-06-04.

Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
424
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Functional Dyspepsia
  • Scarred Peptic Ulcer
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In context

Peptic Ulcer

193 studies on the registry are indexed under Peptic Ulcer; 31 are open to participants now.

This study's enrollment of 424 is above the median of 150 across 142 interventional studies indexed under Peptic Ulcer.

Browse Peptic Ulcer studies →

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
424 participants (actual)

Study arms

  • Experimental
    tetracycline/furazolidone

    one of the four empirical rescue therapies

    Drug: Proton Pump Inhibitor · Drug: Bismuth · Drug: Tetracycline · Drug: Furazolidone

  • Experimental
    amoxicillin/tetracycline

    one of the four empirical rescue therapies

    Drug: Proton Pump Inhibitor · Drug: Bismuth · Drug: Tetracycline · Drug: Amoxicillin

  • Experimental
    amoxicillin/furazolidone

    one of the four empirical rescue therapies

    Drug: Proton Pump Inhibitor · Drug: Bismuth · Drug: Furazolidone · Drug: Amoxicillin

  • Active comparator
    tetracycline /metronidazole

    Classical rescue therapy

    Drug: Proton Pump Inhibitor · Drug: Bismuth · Drug: Metronidazole · Drug: Tetracycline

Interventions

  • DrugProton Pump Inhibitor

    Also known as: Lansoprazole

  • DrugBismuth

    Also known as: Bismuth potassium citrate

  • DrugMetronidazole
  • DrugTetracycline
  • DrugFurazolidone
  • DrugAmoxicillin
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What researchers measure

Primary outcomes

  1. eradication rate of H. pylori

    Time frame: 2 months

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Study locations

1 site
  • Renji Hospital
    Shanghai, Shanghai 200127, China
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References and documents

Publications

  • 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. PubMed 23376004 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01668927
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Responsible party
Dr. HONG LU (professor of GI Division, Renji Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Aug 20, 2012
Start date
Jul 2012
Primary completion
Sep 2012
Completion
Oct 2012
Last update
Jun 4, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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