Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Quadruple Therapy

Primary Measures

• Eradication of H. pylori infection resistant to triple therapy.
  • Time Frame: 6 weeks
    Safety Issue?: No

Secondary Measures

• Safety of the quadruple therapy
  • Time Frame: 6 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Aga Khan University

Overall Clinical Trial Officials and Contacts

Zaigham Abbas, FACG Principal Investigator Aga Khan University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00520949

Study ID Number: 609-Med

ClinicalTrials.gov Identifier: NCT00520949

Health Authority: Pakistan: Research Ethics Committee