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

NCT00713947 | Withdrawn Phase 4 DMC

• 2 other identifiers: P051021AOM 05114
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Thrombosis; Supra-aortic Artery Thrombosis; Positive Helicobacter Pylori Serology

Keywords

Gastric lesions induced by low dose of aspirin; Helicobacter pylori

Outcome Measures

Primary Outcomes (1)

• Measure: severity of the ulcerated gastric lesions induced by the aspirin

  6 months

Secondary Outcomes (6)

• 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

  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

Study Arms (3)

A

ACTIVE COMPARATOR

Amoxicillin, Clarythromycin or metronidazole,Pantoprazole,Placebo

Drug: during one week for the active treatments

B

EXPERIMENTAL

Pantoprazole

Drug: Pantoprazole

C

PLACEBO COMPARATOR

Placebo

Drug: Placebo Formula 515

Interventions

Placebo Formula 515 DRUG

26 weeks, one tablet per day

C

during one week for the active treatments DRUG

during one week for the active treatments placebo during 25 weeks

Also known as: Amoxicillin, Clarythromycin or metronidazole, Pantoprazole, Placebo

A

Pantoprazole DRUG

6 months at 20 mg

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

You may not qualify if:

• Treatment by methotrexate in progress or stopped since less 3 months.
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hotel Dieu Hospital

Paris, 75181, France

Location

MeSH Terms

Conditions

Coronary Thrombosis

Interventions

Amoxicillin; Metronidazole; Pantoprazole

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Thrombosis; Embolism and Thrombosis; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Benzimidazoles

Study Officials

• Dominique Lamarque, MD, PhD

  Assistance Publique Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: July 14, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2010
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

FR (1)