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

This study has been completed.
Sponsor:
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00520949
First received: August 24, 2007
Last updated: April 7, 2009
Last verified: April 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of the quadruple therapy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Aga Khan University

Additional 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
Study First Received: August 24, 2007
Last Updated: April 7, 2009
Health Authority: Pakistan: Research Ethics Committee

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
Bismuth
Omeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antacids
 Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents, Urinary
Renal Agents
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2013