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...
Date First Received: August 24, 2007
Last Updated: August 24, 2007
Verified by: Aga Khan University, August 2007
Clinical Trial Phase: N/A | Start Date: October 2006
Overall Status: Recruiting
Estimated Enrollment: 48
Brief Summary
Official Title: “Quadruple Therapy Using Esomeprazole, Colloidal Bismuth Subcitrate, Amoxicillin-Clavulanate, and Furazolidone in Patients Who Failed to Eradicate H. Pylori With Triple Therapy”
Condition Keyword(s):
Intervention(s):
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 7-14 days.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Quadruple therapy
- Amoxicillin-clavulanic acid 1gram b.i.d; furazolidone 200mg b.i.d; colloidal bismuth subcitrate 240mg b.i.d;esomeprazole 40mg b.i.d for 14 days.
Outcome Measures for this Clinical Trial
Primary Measures
- Eradication of H. pylori infection resistant to triple therapy.
- Time Frame: 6 weeks
- Time Frame: 6 weeks
Secondary Measures
- Safety of the quadruple therapy
- Time Frame: 6 weeks
- Time Frame: 6 weeks
Criteria for Participation in this Clinical Trial
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
Clinical Trial Sponsor Information
Lead Sponsor: Aga Khan University
Overall Clinical Trial Officials and Contacts
Zaigham Abbas, FACG Principal Investigator Aga Khan University
Overall Contact: Zaigham Abbas, FACG 92214930051 zaigham@akunet.org
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
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
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