GERDLINEANCT00695838

National Survey on Gastroesophageal Reflux Disease (GERD) Patients

An observational study of GERD, run by AstraZeneca at 1,624 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 observational study is to assess the impact of abdominal fat on severity and frequency of GERD symptoms . Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: GERD
How many people: 5,084 participants
Where: 1,624 sitesFrance
Study dates: Jan 2008to Dec 2008
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: First three consecutive patients with GERD symptoms seen by GP

Who may be able to join

Male or female > or = 18 years old
Patient with symptomatic GERD
Without PPI or H2 antagonist treatment during the 3 previous months
Agree to take part in this study

Who cannot join

Pregnant women

Trial locations and contacts

1,624 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

France300 sites

Research Site
Ablon-sur-Seine
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Achenheim
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Afa
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Agde
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Agen
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Agneaux
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Aigre
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Aigrefeuille SUR MAI
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Aire-sur-la-Lys
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Aiserey
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Aix-en-Provence
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Aix-les-Bains
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Ajaccio
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Alba-la-Romaine
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Albertville
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Albi
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Alençon
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Alès
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Ambazac
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Ambès
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Ambierle
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Ambilly
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Ambleteuse
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Amboise
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Amelie LES Bains CED
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Amiens
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Amphion-les-Bains
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Amplepuis
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Andernos-les-Bains
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Andrézieux-Bouthéon
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Angers
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Anglet
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Angoulême
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Aniche
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Annay
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Annecy
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Annecy-le-Vieux
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Annezin
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Annonay
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Anse
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Antibes
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Antony
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Anzin
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Apprieu
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Apt
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ARC ET Senans RC ET Senans
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Arcachon
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Arches
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Argences
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Argentat
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Argenteuil
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Argentré-du-Plessis
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Arles
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Armentières
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Arpajon
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Arradon
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Arras
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Art-sur-Meurthe
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Artenay
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Arthon-en-Retz
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Arudy
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Arzano
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Arzon
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Asnières-sur-Seine
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Aspiran
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Asson
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Athies
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Athis-Mons
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Aubagne
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Aubenas
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Aubervilliers
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Aubière
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Aubigny
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Auch
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Auchel
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Auchy-les-Mines
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Audruicq
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Audun-le-Roman
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Aulnay-sous-Bois
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Aumale
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Auray
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Aurillac
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Auriol
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Authon-du-Perche
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Autun
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Auxerre
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Auxonne
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Availles-Limouzine
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Avelin
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Avesnelles
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Avesnes-les-Aubert
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Avignon
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Axat
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Aytré
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Azay-le-Ferron
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Azerailles
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Badevel
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Bâgé-le-Châtel
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Bagneux Saumur
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Bagnols-sur-Cèze
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Baillargues
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Bailleul
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Balan
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Balbigny
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Ballon
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Balma
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Bapaume
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Bar-le-Duc
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Barbezieux Saint Hilair
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Barentin
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Barlin
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Basse-Goulaine
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Bassussarry
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Bastia
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Baugé
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Baulon
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Baume-les-Dames
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Bayonne
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Beaucaire
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Beaucouzé
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Beaumont
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Beaumont-de-Pertuis
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Beaumont-lès-Valence
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Beaune
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Beauregard-l'Évêque
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Beausoleil
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Beauvais
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Beauzelle
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Bécon-les-Granits
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Bégard
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Belfort
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Belgodère
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Bellac
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Bellême
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Belleneuve
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Belleville-sur-Meuse
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Belz
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Benfeld
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Bérat
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Bergerac
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Bergholtz
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Berre-l'Étang
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Bersée
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Berson
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Besançon
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Bessé-sur-Braye
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Bessines SUR Gartemp
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Beuvillers
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Beuvry
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Béville-le-Comte
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Béziers
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Biarritz
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Billom
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Billy-Montigny
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Billy-sur-Aisne
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Bischheim
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Bizanos
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Bize-Minervois
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Blaesheim
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Blanquefort
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Blaye
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Blenod LES PONT A MO
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Blérancourt
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Blois
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Blotzheim
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Bobigny
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Boeil-Bezing
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Boën-sur-Lignon
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Bois-Colombes
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Bois-Guillaume
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Bois-le-Roi
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Boiscommun
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Boisseuil
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Bolbec
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Bompas
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Bon-Encontre
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Bondy
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Bonneval
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Boos
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Bordeaux
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Bordères-sur-l'Échez
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Bormes-les-Mimosas
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Bort-les-Orgues
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Boucau
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Bouffémont
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Bouguenais
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Boujan-sur-Libron
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Boulbon
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Boulogne-Billancourt
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Boulogne-sur-Mer
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Bourg-Achard
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Bourg-de-Péage
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Bourg-des-Comptes
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Bourg-en-Bresse
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Bourg-la-Reine
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Bourg-Lastic
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Bourg-lès-Valence
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Bourges
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Bourron-Marlotte
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Boussac
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Boussy-Saint-Antoine
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Brancourt-le-Grand
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Branne
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Brax
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Bray-sur-Seine
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Brégnier-Cordon
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Brest
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Breteuil
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Brezolles
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Brie
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Brie-Comte-Robert
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Brillac
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Brimeux
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Brion-près-Thouet
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Briouze
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Brives-Charensac
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Bron
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Brou
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Broût-Vernet
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Brouvelieures
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Bruay-la-Buissière
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Bruay-sur-l'Escaut
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Bruges
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Buc
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Buchelay
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Buchy
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Bucy-le-Long
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Bulgnéville
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Bures-sur-Yvette
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Cabannes
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Cachan
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Cadaujac
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Caen
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Cagnes-sur-Mer
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Cahors
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Calais
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Callac de Bretagne
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Caluire-et-Cuire
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Cambes
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Cambrai
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Cambremer
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Camon
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Campan
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Campbon
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Camphin EN Carembaul
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Canet-en-Roussillon
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Cannes
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Cannes-Écluse
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Canteleu
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Capbreton
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Capdenac-Gare
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Capestang
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Cappelle-en-Pévèle
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Cappelle-la-Grande
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Carantec
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Carcassonne
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Carentan
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Carignan
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Carnac
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Carnoux-en-Provence
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Caromb
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Carpentras
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Carquefou
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Carresse-Cassaber
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Cartignies
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Carvin
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Cassel
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Cassis
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Castanet Tolosan CED
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Castelnau-de-Guers
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Castelnau-le-Lez
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Castelnau-Montratier
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Castres
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Caulnes
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Cauterets
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Cavaillon
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Caylus
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Cendras
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Cenon
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Cérans-Foulletourte
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Cérences
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Cergy
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Cergy-Pontoise
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Cérilly
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Cervione
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Cesson-Sévigné
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Châbons
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Chabris
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Chalabre
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Chalon-sur-Saône
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Châlons-en-Champagne
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Chambéry
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Chambon-sur-Voueize
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Chamonix
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Champagne AU MONT D
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Champagné-les-Marais
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Champagne-sur-Oise
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Champcueil
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Champigny-sur-Marne
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Champniers

Other trials in France

About this study

Official title: Evaluation of the Impact of Abdominal Fat on GERD Severity and GERD Frequency in General Practice

The purpose of this observational study is to assess the impact of abdominal fat on severity and frequency of GERD symptoms .

Conditions: GERD
Keywords: GERD symptoms- Waist circumference, Patients with symptomatic GERD
Medical subject headings: Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00695838
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.

Waist circumference
Measured: Once

Secondary outcomes (2)

Frequency of GERD symptoms
Measured: Once
GERD impact scale
Measured: Once

Timeline

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

Jan 2008Dec 2008

First posted12 Jun 2008 (estimated)
Study startJan 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for GERDStudies 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: Prospective
Enrolment: 5,084 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00695838
Sponsor's protocol ID: NIS-GFR-DUM-2007/3
Acronym: LINEA
Status last verified: Aug 2009
First submitted: 10 Jun 2008
Last updated: 6 Aug 2009
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

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD

All GERD trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Impact of Abdominal Fat on GERD Severity and GERD Frequency in General Practice
ClinicalTrials.gov ID: NCT00695838
Acronym / sponsor ID: LINEA / NIS-GFR-DUM-2007/3
Conditions: GERD
Keywords: GERD symptoms- Waist circumference, Patients with symptomatic GERD
Study type: Observational
Recruitment status: Completed
Enrolment: 5,084 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jan 2008
Study completion: Dec 2008 (actual)
First posted: 12 Jun 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.

The purpose of this observational study is to assess the impact of abdominal fat on severity and frequency of GERD symptoms .

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
1	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: First three consecutive patients with GERD symptoms seen by GP

Key inclusion criteria (4 listed)

Male or female > or = 18 years old
Patient with symptomatic GERD
Without PPI or H2 antagonist treatment during the 3 previous months
Agree to take part in this study

Key exclusion criteria (1 listed)

Pregnant women

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

Waist circumference
Time frame: Once

2 secondary outcomes

Frequency of GERD symptoms
Time frame: Once
GERD impact scale
Time frame: Once

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 6 Aug 2009.

Related trials for GERD

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD

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.

Alain Castaigne, Medical Director study director

AstraZeneca

1,624 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of GERD, run by AstraZeneca at 1,624 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 4 inclusion and 1 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 6 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1,624 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?

Waist circumference (time frame: Once). 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 NCT00695838.

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 6 Aug 2009.