Self-administered Questionnaire to PatientsNCT01238809
Gastroprotective Agent Utilization and Compliance in Patients > 60 Years Taking Low-dose Aspirin in France
An observational study of Self-administered Questionnaire to Patients, run by AstraZeneca.
Trial summary
The purpose of this study is to assess in general population low-dose aspirin and gastroprotective agent compliance and reasons for bad compliance Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Self-administered Questionnaire to Patients
- How many people
- 7,300 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jul 2011
- Phase
- Observational
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- French people > 60 years old, part of Kantar Health Access Sant� panel
Who cannot join
None listed.
About this study
The purpose of this study is to assess in general population low-dose aspirin and gastroprotective agent compliance and reasons for bad compliance
- Keywords
- Compliance, France
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
low-dose aspirin and gastroprotective treatment compliance (Girerd questionnaire: a 6-item self-administered and validated questionnaire to evaluate adherence to treatments)
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startJun 2011
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-administered Questionnaire to PatientsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 7,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mrs Genevieve BONNELYE, Principal investigator, KantarHealth - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238809
- Sponsor's protocol ID
- NIS-CFR-DUM-2010/1
- Status last verified
- Jun 2011
- First submitted
- 9 Nov 2010
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastroprotective Agent Utilization and Compliance in Patients > 60 Years Taking Low-dose Aspirin in France
- ClinicalTrials.gov ID
- NCT01238809
- Acronym / sponsor ID
- NIS-CFR-DUM-2010/1
- Keywords
- Compliance, France
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 7,300 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 11 Nov 2010 (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.
The purpose of this study is to assess in general population low-dose aspirin and gastroprotective agent compliance and reasons for bad compliance
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (1 listed)
- French people > 60 years old, part of Kantar Health Access Sant� panel
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
low-dose aspirin and gastroprotective treatment compliance (Girerd questionnaire: a 6-item self-administered and validated questionnaire to evaluate adherence to treatments)
Time frame: One month
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 8 Jun 2011.
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.
Mrs Genevieve BONNELYE principal investigator
KantarHealth - France
Questions about this trial
What is this clinical trial studying?
An observational study of Self-administered Questionnaire to Patients, run by AstraZeneca.
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 1 inclusion and 0 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 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
low-dose aspirin and gastroprotective treatment compliance (Girerd questionnaire: a 6-item self-administered and validated questionnaire to evaluate adherence to treatments) (time frame: One month). 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 8 Jun 2011; AzTrials last refreshed its copy on 5 Nov 2026.