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The purpose of the study is assess whether the various forms of triple regimen of administration of treatment of Helicobacter pylori (before meals (fasting), after meals, and any independent mealtime) influence the rate of eradication of this bacterium.
Phase IV, open, randomized, prospective study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1 | Experimental | Esomeprazole, Amoxicillin, Clarythromycin - Administration of 20 mg esomeprazole, 1 g amoxicillin, and 500 mg clarithromycin together, in fasting conditions, twice daily |
|
| Test 2 | Experimental | Esomeprazole, Amoxicillin, Clarythromycin - Administration of 20 mg esomeprazole, 1 g amoxicillin, and 500 mg clarithromycin together, after meals, twice daily |
|
| Test 3 | Experimental | Esomeprazole, Amoxicillin, Clarythromycin - Administration of 20 mg esomeprazole, 1 g amoxicillin, and 500 mg clarithromycin together, twice daily in schedules variables with an interval of at least 8 hours between the doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food effect | Other |
| ||
| Esomeprazole |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of H pylori eradication | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| side effects in each of the forms of triple therapy administration and compare them | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Decio Chinzon, Phd | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade de São Paulo | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Drug |
|
| Amoxicillin | Drug |
|
| Clarythromycin | Drug |
|
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |