Positive Helicobacter Pylori SerologyPhase 4AspyloriNCT00713947
Effectiveness of the Eradication of Helicobacter Pylori and an Inhibitor of Pump With Proton Versus Control
A Phase 4 study testing during one week for the active treatments and Pantoprazole in people with Positive Helicobacter Pylori Serology and Coronary Thrombosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Positive Helicobacter Pylori Serology, Coronary Thrombosis, Supra-aortic Artery Thrombosis
- What is being tested?
- during one week for the active treatments and Pantoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2008to Mar 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Positive Helicobacter Pylori Serology, Coronary Thrombosis, Supra-aortic Artery Thrombosis
- Being tested
- during one week for the active treatments, Pantoprazole, Placebo Formula 515
- Keywords
- Gastric lesions induced by low dose of aspirin, Helicobacter pylori
- Medical subject headings
- Coronary Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
during one week for the active treatmentsDrug
Also called Amoxicillin, Clarythromycin or metronidazole, Pantoprazole, Placebo
during one week for the active treatments placebo during 25 weeks
PantoprazoleDrug
6 months at 20 mg
Placebo Formula 515Drug
26 weeks, one tablet per day
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Amoxicillin, Clarythromycin or metronidazole,Pantoprazole,Placebo Receives: Drug: during one week for the active treatments |
| B | Experimental | Pantoprazole Receives: Drug: Pantoprazole |
| C | Placebo comparator | Placebo Receives: Drug: Placebo Formula 515 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: severity of the ulcerated gastric lesions induced by the aspirin
Measured: 6 months
Secondary outcomes (6)
To measure: percentage of patients having had at least an ulcer
Measured: 6 months
To measure: the average of the ranks of lesion in antrum and corpus.
Measured: 6 months
To measure percentage of patients having had digestive clinical events
Measured: 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
Measured: 6 months
To measure Percentage of patients having a hemorrhagic digestive of clinical expression or detected by the biological tests.
Measured: 6 months
To measure : Elements of the histopathologic score of Sydney
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2009
- Study completionMar 2010
Why it stopped: no inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive Helicobacter Pylori SerologyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Dominique Lamarque, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713947
- Sponsor's protocol ID
- P051021
- Other IDs
- AOM 05114
- Acronym
- Aspylori
- Status last verified
- Mar 2026
- First submitted
- 18 Jun 2008
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00713947
- Acronym / sponsor ID
- Aspylori / P051021
- Conditions
- Positive Helicobacter Pylori Serology, Coronary Thrombosis, Supra-aortic Artery Thrombosis
- Keywords
- Gastric lesions induced by low dose of aspirin, Helicobacter pylori
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no inclusion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Apr 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: during one week for the active treatmentsAmoxicillin, Clarythromycin or metronidazole,Pantoprazole,Placebo |
| B | Experimental | Drug: PantoprazolePantoprazole |
| C | Placebo comparator | Drug: Placebo Formula 515Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| during one week for the active treatmentsAlso: Amoxicillin, Clarythromycin or metronidazole, Pantoprazole, Placeboduring one week for the active treatments placebo during 25 weeks | Drug | A |
| Pantoprazole6 months at 20 mg | Drug | B |
| Placebo Formula 51526 weeks, one tablet per day | Drug | C |
Primary outcome
Measure: severity of the ulcerated gastric lesions induced by the aspirin
Time frame: 6 months
6 secondary outcomes
To measure: percentage of patients having had at least an ulcer
Time frame: 6 months
To measure: the average of the ranks of lesion in antrum and corpus.
Time frame: 6 months
To measure percentage of patients having had digestive clinical events
Time frame: 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
Time frame: 6 months
To measure Percentage of patients having a hemorrhagic digestive of clinical expression or detected by the biological tests.
Time frame: 6 months
To measure : Elements of the histopathologic score of Sydney
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Lamarque, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing during one week for the active treatments and Pantoprazole in people with Positive Helicobacter Pylori Serology and Coronary Thrombosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure: severity of the ulcerated gastric lesions induced by the aspirin (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.