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| ID | Type | Description | Link |
|---|---|---|---|
| AOM 05114 |
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no inclusion
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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Low dose of aspirin is the main cause of gastro-duodenal ulcer. The best prevention is not definite particularly in patients without history of ulcer and infected by H. pylori.The aim of the study is to evaluate the gastric damage induced by aspirin in patients with H. pylori infection but who have any history of ulcer.
The aim of the study is to compare the protective effect of H. pylori eradication versus Pantoprazole versus placebo on the gastric damage induced by low dose of aspirin. Treatment are attributed by randomisation. Patients are followed for 6 months and gastric damage are evaluated by endoscopy at the end of this period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Amoxicillin, Clarythromycin or metronidazole,Pantoprazole,Placebo |
|
| B | Experimental | Pantoprazole |
|
| C | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| during one week for the active treatments | Drug | during one week for the active treatments placebo during 25 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure: severity of the ulcerated gastric lesions induced by the aspirin | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To measure: percentage of patients having had at least an ulcer | 6 months | |
| To measure: the average of the ranks of lesion in antrum and corpus. | 6 months | |
| To measure percentage of patients having had digestive clinical events |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominique Lamarque, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel Dieu Hospital | Paris | 75181 | France |
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| Pantoprazole | Drug | 6 months at 20 mg |
|
| Placebo Formula 515 | Drug | 26 weeks, one tablet per day |
|
| 6 months |
| To measure: the average of the ranks of severity of the hemorrhagic lesions and erosive lesions evaluated in antrum and corpus by two analogical scales of 150 mm | 6 months |
| To measure Percentage of patients having a hemorrhagic digestive of clinical expression or detected by the biological tests. | 6 months |
| To measure : Elements of the histopathologic score of Sydney | 6 months |
| ID | Term |
|---|---|
| D003328 | Coronary Thrombosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D008795 | Metronidazole |
| D000077402 | Pantoprazole |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
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