HealthyNCT01211652

Gastroprotective Agent Utilization and Compliance in Elderly Patients Taking Non-steroidal Anti-inflammatory Drug (NSAID) in France

An observational study of Healthy, run by AstraZeneca at 3,510 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to assess in general population NSAID and gastroprotective agent utilization and compliance in elderly people. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
How many people: 8,186 participants
Where: 3,510 sitesFrance
Study dates: Oct 2010to Nov 2010
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 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Study population: Community sample

Who may be able to join

French people > 65 years old, part of Kantar Health Access Santé panel

Who cannot join

None listed.

Trial locations and contacts

3,510 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

France300 sites

Research Site
Abancourt
Research Site
Ablain-Saint-Nazaire
Research Site
Ablis
Research Site
Ablon-sur-Seine
Research Site
Abscon
Research Site
Achères
Research Site
Achery
Research Site
Achicourt
Research Site
Achiet-le-Grand
Research Site
Adelans-et-le-val-de-bitha
Research Site
Adissan
Research Site
Agde
Research Site
Agen
Research Site
Agneaux
Research Site
Aiffres
Research Site
Aiglun
Research Site
Aigrefeuille-sur-Maine
Research Site
Aigues-Vives
Research Site
Aillevillers-et-Lyaumont
Research Site
Ailly-sur-Somme
Research Site
Aimargues
Research Site
Aime
Research Site
Aisey-sur-Seine
Research Site
Aïssey
Research Site
Aix
Research Site
Aix-en-Provence
Research Site
Aix-les-Bains
Research Site
Aix-Noulette
Research Site
Aixe-sur-Vienne
Research Site
Aizier
Research Site
Ajaccio
Research Site
Albert
Research Site
Albertville
Research Site
Albi
Research Site
Alençon
Research Site
Alénya
Research Site
Alès
Research Site
Alfortville
Research Site
Alignan-du-Vent
Research Site
Allauch
Research Site
Allemans
Research Site
Allenjoie
Research Site
Alligny-Cosne
Research Site
Allonnes
Research Site
Alloue
Research Site
Almenêches
Research Site
Alvimare
Research Site
Alzonne
Research Site
Amance
Research Site
Amancy
Research Site
Amanvillers
Research Site
Ambazac
Research Site
Ambérieu-en-Bugey
Research Site
Ambert
Research Site
Ambès
Research Site
Ambleteuse
Research Site
Ambly-sur-Meuse
Research Site
Amboise
Research Site
Ambrumesnil
Research Site
Amfreville-la-Campagne
Research Site
Amfreville-les-Champs
Research Site
Amiens
Research Site
Amilly
Research Site
Ancelle
Research Site
Ancenis
Research Site
Ancerville
Research Site
Ancinnes
Research Site
Andard
Research Site
Andernos-les-Bains
Research Site
Andrésy
Research Site
Anduze
Research Site
Anères
Research Site
Anet
Research Site
Angers
Research Site
Angeville
Research Site
Angey
Research Site
Angicourt
Research Site
Anglars
Research Site
Angles
Research Site
Anglet
Research Site
Angoulême
Research Site
Angoulins
Research Site
Aniche
Research Site
Anjouin
Research Site
Annecy
Research Site
Annecy-le-Vieux
Research Site
Annemasse
Research Site
Anneville-sur-Mer
Research Site
Annoeullin
Research Site
Annonay
Research Site
Anse
Research Site
Anstaing
Research Site
Antheny
Research Site
Antibes
Research Site
Antony
Research Site
Antugnac
Research Site
Anzin
Research Site
Aouste-sur-Sye
Research Site
Appoigny
Research Site
Apremont
Research Site
Apt
Research Site
Aranc
Research Site
Arbonne
Research Site
Arbonne-la-Forêt
Research Site
Arc-lès-Gray
Research Site
Arçais
Research Site
Arcenant
Research Site
Archettes
Research Site
Arcueil
Research Site
Ardentes
Research Site
Aregno
Research Site
Arfeuilles
Research Site
Argeles
Research Site
Argent-sur-Sauldre
Research Site
Argentan
Research Site
Argentat
Research Site
Argenteuil
Research Site
Argentré
Research Site
Argonay
Research Site
Arles
Research Site
Arleux
Research Site
Armentières
Research Site
Arnage
Research Site
Arnèke
Research Site
Arnouville
Research Site
Arpaillargues-et-Aureillac
Research Site
Arpajon
Research Site
Arques
Research Site
Arquian
Research Site
Arrancy-sur-Crusnes
Research Site
Arras
Research Site
Arrènes
Research Site
Ars-Laquenexy
Research Site
Ars-sur-Moselle
Research Site
Arsac
Research Site
Arsac-en-Velay
Research Site
Artannes-sur-Thouet
Research Site
Arthon-en-Retz
Research Site
Asasp-Arros
Research Site
Ascain
Research Site
Asnan
Research Site
Asnières-sur-Nouère
Research Site
Asnières-sur-Oise
Research Site
Asnières-sur-Seine
Research Site
Assais-les-Jumeaux
Research Site
Astaffort
Research Site
Astugue
Research Site
Athis-Mons
Research Site
Aubagne
Research Site
Aubais
Research Site
Aubergenville
Research Site
Aubervilliers
Research Site
Aubevoye
Research Site
Aubière
Research Site
Aubigné
Research Site
Aubigny-sur-Nère
Research Site
Aubord
Research Site
Auboué
Research Site
Aucamville
Research Site
Auch
Research Site
Auchel
Research Site
Audincourt
Research Site
Aulnat
Research Site
Aulnay-la-Rivière
Research Site
Aulnay-sous-Bois
Research Site
Aulnoy
Research Site
Aulnoy-lez-Valenciennes
Research Site
Aulnoye-Aymeries
Research Site
Aumâtre
Research Site
Aumetz
Research Site
Aumont-Aubrac
Research Site
Auray
Research Site
Aurec-sur-Loire
Research Site
Aureilhan
Research Site
Auribeau-sur-Siagne
Research Site
Aurillac
Research Site
Aussac-Vadalle
Research Site
Aussillon
Research Site
Auterive
Research Site
Authon-Ébéon
Research Site
Autignac
Research Site
Autun
Research Site
Auvers-sur-Oise
Research Site
Auxerre
Research Site
Auxonne
Research Site
Auzainvilliers
Research Site
Auzances
Research Site
Avanton
Research Site
Avelin
Research Site
Avermes
Research Site
Avesnes-Chaussoy
Research Site
Avesnes-le-Comte
Research Site
Avesnes-sur-Helpe
Research Site
Avignon
Research Site
Avion
Research Site
Avoine
Research Site
Avon
Research Site
Ayat-sur-Sioule
Research Site
Aytré
Research Site
Azay-le-Rideau
Research Site
Azelot
Research Site
Azereix
Research Site
Badonviller
Research Site
Bages
Research Site
Bagneux
Research Site
Bagnolet
Research Site
Bagnols-en-Forêt
Research Site
Bagnols-sur-Cèze
Research Site
Baigts-de-Béarn
Research Site
Baillet-en-France
Research Site
Bailleul
Research Site
Bailleul-Sir-Berthoult
Research Site
Bailly-Romainvilliers
Research Site
Baisieux
Research Site
Ballan-Miré
Research Site
Ballons
Research Site
Balma
Research Site
Banassac
Research Site
Bangor
Research Site
Bar-le-Duc
Research Site
Bar-sur-Aube
Research Site
Bar-sur-Seine
Research Site
Barbentane
Research Site
Barberaz
Research Site
Barberey-Saint-Sulpice
Research Site
Bardenac
Research Site
Bardouville
Research Site
Barjac
Research Site
Barlin
Research Site
Barneville-Carteret
Research Site
Barr
Research Site
Bassens
Research Site
Bastia
Research Site
Batilly
Research Site
Baudoncourt
Research Site
Baudreix
Research Site
Baule
Research Site
Bauné
Research Site
Bauvin
Research Site
Bayeux
Research Site
Bayon
Research Site
Bayonne
Research Site
Bazancourt
Research Site
Bazoches-lès-Bray
Research Site
Bazoilles-sur-Meuse
Research Site
Beaucaire
Research Site
Beaucamps-le-Vieux
Research Site
Beauchamps
Research Site
Beaufay
Research Site
Beaufort
Research Site
Beaufort-sur-Gervanne
Research Site
Beaugency
Research Site
Beaulieu
Research Site
Beaulieu-sur-Loire
Research Site
Beaulieu-sur-Mer
Research Site
Beaulon
Research Site
Beaumé
Research Site
Beaumes-de-Venise
Research Site
Beaumont-du-Ventoux
Research Site
Beaumont-sur-Dême
Research Site
Beaune
Research Site
Beaurains
Research Site
Beausoleil
Research Site
Beautor
Research Site
Beauvais
Research Site
Beauvallon
Research Site
Beauvène
Research Site
Beauvoisin
Research Site
Bécon-les-Granits
Research Site
Bédarieux
Research Site
Bédoin
Research Site
Bégadan
Research Site
Bégard
Research Site
Bègles
Research Site
Behonne
Research Site
Belfort
Research Site
Belfort-du-Quercy
Research Site
Bellac
Research Site
Bellaing
Research Site
Bellegarde
Research Site
Bellegarde-en-Marche
Research Site
Bellême
Research Site
Bellerive-sur-Allier
Research Site
Belleu
Research Site
Belleville
Research Site
Belley
Research Site
Belligné
Research Site
Belloy-en-France
Research Site
Belrupt
Research Site
Bénaménil
Research Site
Bendejun
Research Site
Bénesse-Maremne
Research Site
Benest
Research Site
Benet
Research Site
Benfeld
Research Site
Benon
Research Site
Berck
Research Site
Bergueneuse
Research Site
Berlaimont
Research Site
Bernaville

Other trials in France

About this study

The purpose of this study is to assess in general population NSAID and gastroprotective agent utilization and compliance in elderly people.

Conditions: Healthy
Keywords: Compliance, France, Self-administered questionnaire to patients
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 groups in NCT01211652
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.

NSAID Treatment Compliance
Measured: At the end of month 1
Gastroprotective agent compliance (Girerd Questionnaire)
Measured: At the end of month 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010Nov 2010

First posted29 Sep 2010 (estimated)
Study startOct 2010
Primary completionNov 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies 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: 8,186 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01211652
Sponsor's protocol ID: NIS-PFR-DUM-2010/1
Status last verified: Jan 2013
First submitted: 20 Sep 2010
Last updated: 29 Jan 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Gastroprotective Agent Utilization and Compliance in Elderly Patients Taking Non-steroidal Anti-inflammatory Drug (NSAID) in France
ClinicalTrials.gov ID: NCT01211652
Acronym / sponsor ID: NIS-PFR-DUM-2010/1
Conditions: Healthy
Keywords: Compliance, France, Self-administered questionnaire to patients
Study type: Observational
Recruitment status: Completed
Enrolment: 8,186 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 29 Sep 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 NSAID and gastroprotective agent utilization and compliance in elderly people.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
1	–	–

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult
Study population: Community sample

Key inclusion criteria (1 listed)

French people > 65 years old, part of Kantar Health Access Santé 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

NSAID Treatment Compliance
Time frame: At the end of month 1
Gastroprotective agent compliance (Girerd Questionnaire)
Time frame: At the end of month 1

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.

Related trials for Healthy

Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers

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.

Dr Jean-Francois Bretagne study chair

Service gastro-enterologie et hepatologie CHRU Pontchaillou 35033 RENNES cedex France

Pr Gerard Thiefin study chair

Service Hepato-Gastroenterologie CHU Reims 51092 REIMS cedex France

Mrs Genevieve BONNELYE principal investigator

KantarHealth - France138, avenue Marx Dormoy 92120 Montrouge cedex

3,510 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by AstraZeneca at 3,510 sites 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 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: finished, as of the sponsor's last update on 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3,510 sites 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

NSAID Treatment Compliance (time frame: At the end of month 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01211652.

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 29 Jan 2013; AzTrials last refreshed its copy on 31 Oct 2026.