- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00520949
Quadruple Therapy for Triple Therapy Resistant Helicobacter Pylori Infection (QT-Hp)
April 7, 2009 updated by: Aga Khan University
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 Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
176
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 74800
- Aga Khan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Quadruple Therapy
|
Amoxicillin-clavulanic acid 1 gram b.i.d
furazolidone 200 mg b.i.d
colloidal bismuth subcitrate 240 mg b.i.d
esomeprazole 40 mg b.i.d for 14 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Eradication of H. pylori infection resistant to triple therapy.
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety of the quadruple therapy
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zaigham Abbas, FACG, Aga Khan University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
August 24, 2007
First Submitted That Met QC Criteria
August 24, 2007
First Posted (Estimate)
August 27, 2007
Study Record Updates
Last Update Posted (Estimate)
April 8, 2009
Last Update Submitted That Met QC Criteria
April 7, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Monoamine Oxidase Inhibitors
- beta-Lactamase Inhibitors
- Antacids
- Anti-Infective Agents, Urinary
- Renal Agents
- Antitrichomonal Agents
- Amoxicillin
- Esomeprazole
- Amoxicillin-Potassium Clavulanate Combination
- Bismuth
- Bismuth tripotassium dicitrate
- Furazolidone
Other Study ID Numbers
- 609-Med
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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