Status:
COMPLETED
Clarithromycin, Amoxicillin, and Metronidazole Based Regimens to Treat Helicobacter Pylori Infections in Colombia
Lead Sponsor:
University of North Texas Health Science Center
Collaborating Sponsors:
Universidad del Valle, Colombia
Vanderbilt University
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
29-77 years
Phase:
PHASE3
Brief Summary
More than half of the world's population is infected with Helicobacter pylori, a bacterium that colonizes the human stomach. Although most infected subjects live free of symptoms and disease outcomes ...
Detailed Description
Warren and Marshall's Noble prize winning discovery of Helicobacter pylori, and their subsequent work which showed that gastritis and peptic ulcers could be successfully treated by eradicating this ba...
Eligibility Criteria
Inclusion
- Aged 29-77 years; have lived in Pasto, Colombia for at least 5 years and plan to remain in Pasto for ≥5 more years;
- Currently have Helicobacter pylori infection;
- Willing to refrain from alcohol consumption for 2 weeks;
- Have never taken a therapy to eradicate Helicobacter pylori;
- Have not taken antibiotics, bismuth compounds, proton-pump inhibitors, H2-receptor antagonists, or antacids within 30 days of the trial;
- Are not pregnant, and have little or no risk of pregnancy.
Exclusion
- History of kidney, liver, heart, or mental disease;
- Frequent alcohol consumption;
- Allergic to clarithromycin, amoxicillin, penicillin, omeprazole or metronidazole;
- Currently taking drugs which may interact with any of the trial medications.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00719420
Start Date
April 1 2006
End Date
February 1 2007
Last Update
July 21 2008
Active Locations (1)
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1
Universidad del Valle
Cali, Colombia