Quadruple Therapy for Triple Therapy Resistant Helicobacter Pylori Infection - Full Text View

Sponsor:	Aga Khan University
Information provided by:	Aga Khan University
ClinicalTrials.gov Identifier:	NCT00520949

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

Drug Information available for: Furazolidone Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Omeprazole Amoxicillin-potassium clavulanate combination Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium Bismuth citrate Bismuth

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
Quadruple Therapy: Experimental	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, Sindh
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 National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	The Aga Khan University Hospital ( Dr Zaigham Abbas )
Study ID Numbers:	609-Med
Study First Received:	August 24, 2007
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00520949 History of Changes
Health Authority:	Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:

H.pylori
Triple therapy failure
Quadruple therapy

Additional relevant MeSH terms:

Anti-Infective Agents
Antiprotozoal Agents
Amoxicillin
Bismuth tripotassium dicitrate
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Pharmacologic Actions

Bismuth
Anti-Bacterial Agents
Anti-Infective Agents, Local
Antiparasitic Agents
Furazolidone
Therapeutic Uses
Anti-Ulcer Agents
Monoamine Oxidase Inhibitors
Antacids
Antitrichomonal Agents

ClinicalTrials.gov processed this record on November 30, 2009