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| Sponsor: | University of North Texas Health Science Center |
|---|---|
| Collaborators: |
Universidad del Valle, Colombia Vanderbilt University |
| Information provided by: | University of North Texas Health Science Center |
| ClinicalTrials.gov Identifier: | NCT00719420 |
Purpose
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 (except superficial gastritis), only a few develop peptic ulcers or gastric cancer, while some others may develop non-ulcer dyspepsia. Current clinical practice for the management of peptic ulcer disease includes testing for and treating H. pylori, if present. Although there are triple therapies that contain 2 antibiotics plus a bismuth compound, a proton-pump inhibitor, or a H2-receptor antagonist which are effective at eliminating H. pylori in Europe and North America, these treatments are dramatically less effective in developing countries. Our recent meta-analysis showed quadruple therapies containing clarithromycin, amoxicillin, metronidazole and a proton pump inhibitor to be effective in the presence of clarithromycin or metronidazole resistance. However, this regimen has yet to be tested in a developing country. Therefore, in the current randomized clinical trial in Pasto, Colombia, we aim to examine the effectiveness of clarithromycin, amoxicillin, metronidazole with and without a proton pump inhibitor compared to the Food and Drug Administration approved 10-day regimen containing clarithromycin, amoxicillin and omeprazole. Since antibiotic therapy is most effective within a specific gastric pH range, and since mutifocal atrophy results in damage and loss of the acid producing parietal cells, we will test the efficacy of our modified therapy stratified by diagnosis of multifocal atrophic gastritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Helicobacter Pylori Infection |
Drug: Clarithromycin, Metronidazole, Amoxicillin (+Omeprazole) Drug: Clarithromycin, Amoxicillin, Omeprazole |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized Clinical Trial to Examine the Efficacy of a Clarithromycin-, Amoxicillin-, and Metronidazole-Based Regimen to Eradicate Helicobacter Pylori Infections in Pasto, Colombia |
| Enrollment: | 151 |
| Study Start Date: | April 2006 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Clarithromycin 500 mg bid, metronidazole 500 mg tid, and amoxicillin 500mg tid for 14 days (with or without omeprazole 20 mg bid)
|
Drug: Clarithromycin, Metronidazole, Amoxicillin (+Omeprazole)
Clarithromycin 500 mg bid, metronidazole 500 mg tid, and amoxicillin 500mg tid with or without omeprazole 20 mg bid for 14 days
|
|
2: Active Comparator
Clarithromycin 500 mg bid, amoxicillin 1 g bid, and omeprazole 20 mg bid for 10 days
|
Drug: Clarithromycin, Amoxicillin, Omeprazole
Clarithromycin 500 mg bid, amoxicillin 1 g bid, and omeprazole 20 mg bid for 10 days
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 29 Years to 77 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Colombia | |
| Universidad del Valle | |
| Cali, Colombia | |
| Principal Investigator: | Lori A Fischbach, PhD, MPH | University of North Texas Health Science Center |
| Study Chair: | Pelayo Correa, MD | Vanderbilt University |
| Study Director: | Luis E Bravo, MD | Universidad del Valle |
More Information
| Responsible Party: | University of North Texas Health Science Center ( Dr. Lori A. Fischbach ) |
| Study ID Numbers: | 06-02-24-2 |
| Study First Received: | July 11, 2008 |
| Last Updated: | July 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00719420 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Randomized clinical trial Helicobacter pylori clarithromycin metronidazole |
amoxicillin proton pump inhibitor Colombia |
|
Communicable Diseases Metronidazole Anti-Infective Agents Amoxicillin Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Omeprazole Enzyme Inhibitors |
Infection Pharmacologic Actions Protein Synthesis Inhibitors Clarithromycin Anti-Bacterial Agents Antiparasitic Agents Radiation-Sensitizing Agents Therapeutic Uses Anti-Ulcer Agents |