Effectiveness of the Eradication of Helicobacter Pylori and an Inhibitor of Pump With Proton Versus Control | RxWiki

Effectiveness of the Eradication of Helicobacter Pylori and an Inhibitor of Pump With Proton Versus Control

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Positive Helicobacter Pylori Serology Coronary Thrombosis Supra-Aortic Artery Thrombosis
Intervention	Drug: during one week for the active treatments Drug: Pantoprazole Drug: Placebo Formula 515
Phase	Phase 4
Sponsor	Assistance Publique - Hôpitaux de Paris
Responsible Party	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier	NCT00713947
First Received	June 18, 2008
Last Updated	October 11, 2010
Last verified	October 2010

Tracking Information[ + expand ][ + ]

First Received Date	June 18, 2008
Last Updated Date	October 11, 2010
Start Date	April 2008
Estimated Primary Completion Date	March 2010
Current Primary Outcome Measures	Measure: severity of the ulcerated gastric lesions induced by the aspirin [Time Frame: 6 months] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	To measure: percentage of patients having had at least an ulcer [Time Frame: 6 months] [Designated as safety issue: Yes] To measure: the average of the ranks of lesion in antrum and corpus. [Time Frame: 6 months] [Designated as safety issue: Yes] To measure percentage of patients having had digestive clinical events [Time Frame: 6 months] [Designated as safety issue: Yes] 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 [Time Frame: 6 months] [Designated as safety issue: Yes] To measure Percentage of patients having a hemorrhagic digestive of clinical expression or detected by the biological tests. [Time Frame: 6 months] [Designated as safety issue: Yes] To measure : Elements of the histopathologic score of Sydney [Time Frame: 6 months] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Effectiveness of the Eradication of Helicobacter Pylori and an Inhibitor of Pump With Proton Versus Control
Official Title	Comparative Effectiveness of the Eradication of Helicobacter Pylori and an Inhibitor of Pump With Proton Versus Control on the Gastric Lesions Induced by the Aspirin With the Low Dose Among Patients Treated With the Long Course
Brief Summary	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.
Detailed Description	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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Condition	Positive Helicobacter Pylori Serology Coronary Thrombosis Supra-Aortic Artery Thrombosis
Intervention	Drug: during one week for the active treatments during one week for the active treatments placebo during 25 weeks Other Names: Amoxicillin Clarythromycin or metronidazole Pantoprazole Placebo Drug: Pantoprazole 6 months at 20 mg Other Names: PantoprazoleDrug: Placebo Formula 515 26 weeks, one tablet per day Other Names: Placebo Formula 515
Study Arm (s)	Active Comparator: A Amoxicillin, Clarythromycin or metronidazole,Pantoprazole,Placebo Experimental: B Pantoprazole Placebo Comparator: C Placebo

Recruitment Information[ + expand ][ + ]

Recruitment Status	Terminated
Estimated Enrollment	Not Provided
Estimated Completion Date	March 2010
Estimated Primary Completion Date	March 2009
Eligibility Criteria	Inclusion Criteria: - Patients of more than 18 years old - Coronarography or coronary imaging or supra-aortic arterial trunks ultrasound examination performed since less 7 months and having at least an arterial vascular stenosis - Indication for aspirin treatment for at least 12 months (at the moment of the visit of inclusion) at a posology from 80 to 125 mg per day. The treatment must be prescribed since less than 7 months. - Patient who had since less 7 month a positive Helicobacter Pylori serology. - For the women in age to procreate, effective mode of contraception (oral contraception, surgical sterilization, coil) - Patient having given an informed consent according to recommendation of the CPP (institutional ethical committee). Exclusion Criteria: - treatment by anti-coagulant, whatever its nature and its posology, by proton pump inhibitor, H2 receptor antagonists or antiacid having to be continued beyond the day of inclusion - Treatment by methotrexate in progress or stopped since less 3 months. - Time of more 7 months enters the beginning of the treatment by aspirin and the visit of inclusion - Treatment by NSAID (even occasional or self medication) under or stopped since less 3 months. - Treatment by anti-platelet drug (clopidogrel, ticlopidine, flurbiprofen, dipyridamole or antagonist of receptor GPIIb/IIIa) in progress or stopped since less than 10 days. - Patient with a serious pathology compromising survival in the 6 month to come. - Patient with renal or respiratory insufficiency or a hepatic pathology having a clinical repercussion. - History of surgery of esophagus, stomach or duodenum. - History of digestive tract bleeding or gastro-duodenal ulcer or esophagal ulcerating proven by endoscopy. - Allergy known to clarithromycin. - Psychiatric disorder not controlled by treatment. - Patients all ready include in a therapeutic protocol or to be followed for 6 month. - Alcohol consumption higher than 100gr. per day. - Patient non suitable for participating in the protocol or to be followed for 6 month. - History of intolerance to salicylate. - Constitutional or acquired hemorrhagic disease - Pregnant woman or nursing. - Patient in emergency, people hospitalized without their assent, people without freedom, people without social health insurance.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	France

Administrative Information[ + expand ][ + ]

NCT Number	NCT00713947
Other Study ID Numbers	P051021
Has Data Monitoring Committee	Yes
Information Provided By	Assistance Publique - Hôpitaux de Paris
Study Sponsor	Assistance Publique - Hôpitaux de Paris
Collaborators	Not Provided
Investigators	Principal Investigator: Dominique Lamarque, MD, PhD Assistance Publique - Hôpitaux de Paris
Verification Date	October 2010

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