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Quadruple Therapy for Triple Therapy Resistant Helicobacter Pylori Infection (QT-Hp)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00520949
First Posted: August 27, 2007
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Aga Khan University
  Purpose
Triple therapy, a combination of proton pump inhibitor with two antibiotics, is the gold standard for anti-Helicobacter pylori treatment. Usual antibiotics are clarithromycin, and either amoxicillin or one of the nitroimidazoles (metronidazole). However, there is an increasing evidence of H. pylori resistance to classical triple therapy. Another reason for this failure being low patient compliance with treatment. A regimen useful in one geographical area may not be effective or practical in another area. The aim of this study was to eradicate H. pylori infection resistant to triple therapy, establish the efficacy and safety of a 14-day therapeutic regimen to eradicate of H. pylori in patients who have failed with the classical triple therapy (omeprazole, clarithromycin and amoxicillin) given for 14 days.

Condition Intervention
Treatment of Helicobacter Pylori Drug: Augmentin (Amoxicillin-clavulanic) Drug: Furoxone (furazolidone) Drug: Cebes (colloidal bismuth subcitrate) Drug: Esso (esomeprazole)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Quadruple Therapy Using Esomeprazole, Colloidal Bismuth Subcitrate, Amoxicillin-Clavulanate, and Furazolidone in Patients Who Failed to Eradicate H. Pylori With Triple Therapy

Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Eradication of H. pylori infection resistant to triple therapy. [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Safety of the quadruple therapy [ Time Frame: 6 weeks ]

Enrollment: 176
Study Start Date: October 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quadruple Therapy Drug: Augmentin (Amoxicillin-clavulanic)
Amoxicillin-clavulanic acid 1 gram b.i.d
Drug: Furoxone (furazolidone)
furazolidone 200 mg b.i.d
Drug: Cebes (colloidal bismuth subcitrate)
colloidal bismuth subcitrate 240 mg b.i.d
Drug: Esso (esomeprazole)
esomeprazole 40 mg b.i.d for 14 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent given by the patient
  • Patients known to have H. pylori infection diagnosed by histopathology, rapid urease test and urea breath test
  • Failure to respond to classical triple regime of amoxicillin 1gram, clarithromycin 500mg and omeprazole 20mg twice a day for 10-14 days as documented by repeat urea breath test done one month after eradication therapy

Exclusion Criteria:

  • Evidence of any malignancy, gastric outlet syndrome, history of gastric surgery, chronic liver disease, severe chronic renal failure, or any major co-morbidity.
  • known or suspected hypersensitivity to the medication used in the study
  Contacts and Locations
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): NCT00520949


Locations
Pakistan
Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Investigators
Principal Investigator: Zaigham Abbas, FACG Aga Khan University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Zaigham Abbas, The Aga Khan University Hospital
ClinicalTrials.gov Identifier: NCT00520949     History of Changes
Other Study ID Numbers: 609-Med
First Submitted: August 24, 2007
First Posted: August 27, 2007
Last Update Posted: October 12, 2017
Last Verified: April 2009

Keywords provided by Aga Khan University:
H.pylori
Triple therapy failure
Quadruple therapy

Additional relevant MeSH terms:
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Bismuth tripotassium dicitrate
Furazolidone
Esomeprazole
Bismuth
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antacids
beta-Lactamase Inhibitors
Anti-Infective Agents, Local
Anti-Infective Agents, Urinary
Renal Agents
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents
Monoamine Oxidase Inhibitors