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Quadruple Therapy for Triple Therapy Resistant Helicobacter Pylori Infection (QT-Hp)
This study has been completed.
Study NCT00520949   Information provided by Aga Khan University
First Received: August 24, 2007   Last Updated: April 7, 2009   History of Changes

August 24, 2007
April 7, 2009
October 2006
June 2008   (final data collection date for primary outcome measure)
Eradication of H. pylori infection resistant to triple therapy. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Eradication of H. pylori infection resistant to triple therapy. [ Time Frame: 6 weeks ]
Complete list of historical versions of study NCT00520949 on ClinicalTrials.gov Archive Site
Safety of the quadruple therapy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Safety of the quadruple therapy [ Time Frame: 6 weeks ]
 
Quadruple Therapy for Triple Therapy Resistant Helicobacter Pylori Infection
Quadruple Therapy Using Esomeprazole, Colloidal Bismuth Subcitrate, Amoxicillin-Clavulanate, and Furazolidone in Patients Who Failed to Eradicate H. Pylori With Triple Therapy

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.

 
 
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Treatment of Helicobacter Pylori
  • Drug: Augmentin (Amoxicillin-clavulanic)
  • Drug: Furoxone (furazolidone)
  • Drug: Cebes (colloidal bismuth subcitrate)
  • Drug: Esso (esomeprazole)
 
Abbas Z, Yakoob J, Abid S, Jafri W, Islam M, Azam Z, Hilal I. Furazolidone, co-amoxiclav, colloidal bismuth Subcitrate, and esomeprazole for patients who failed to eradicate Helicobacter pylori with triple therapy. Dig Dis Sci. 2009 Sep;54(9):1953-7. Epub 2008 Dec 5.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
176
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT00520949
Dr Zaigham Abbas, The Aga Khan University Hospital
609-Med
Aga Khan University
 
Principal Investigator: Zaigham Abbas, FACG Aga Khan University
Aga Khan University
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP