- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01176682
Observational Study on Non-steroid Anti-inflammatory Drugs (NSAIDs) Treated Patients With Arthritic Disorder (EVIDENCE)
June 5, 2012 updated by: AstraZeneca
European Real Life Study on NSAIDs Treated Patients With Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS): Assessment of Pain Relieve, Gastrointestinal (GI) Symptoms, Adherence and Health Resource Consumption
The aim of this study is to find out how patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis receiving NSAID-therapy are treated and managed by their doctor in usual clinical practice, how patients comply with their treatment and how satisfied they are with their treatment.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
1149
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alsemberg, Belgium
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Anthee, Belgium
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Baisy-Thy, Belgium
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Blankenberge, Belgium
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Bois de Villers, Belgium
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Bruxelles, Belgium
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Champion, Belgium
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Chenee, Belgium
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Dour, Belgium
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Ecaussinnes, Belgium
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Fosses-la-Ville, Belgium
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Geel, Belgium
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Genly, Belgium
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Godinne, Belgium
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Gozee, Belgium
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Gribomont, Belgium
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Halen, Belgium
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Ham-sur-Heure Nalinnes, Belgium
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Hasselt, Belgium
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Hove, Belgium
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Kraainem, Belgium
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Libramont-Chevigny, Belgium
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Linkebeek, Belgium
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Lommel, Belgium
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Marchovelette, Belgium
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Melsbroek, Belgium
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Moerkerke-Damme, Belgium
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Mont-sur-Marchienne, Belgium
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Mouscron, Belgium
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Natoye, Belgium
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Oostham, Belgium
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Retie, Belgium
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Ronquieres, Belgium
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Rumst, Belgium
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Saint-Ghislain, Belgium
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Seraing, Belgium
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Sint-Amands, Belgium
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Thuillies, Belgium
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Tremelo, Belgium
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Turnhout, Belgium
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Veurne, Belgium
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Vilvoorde, Belgium
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Zoersel, Belgium
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Arches, France
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Art Sur Meurthe, France
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Aubagne, France
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Banyuls Sur Mer, France
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Bassussarry, France
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Cappelle En Pevele, France
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Castets, France
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Champagnole, France
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Charvieu Chavagneux, France
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Colmar, France
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Couzeix, France
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Firminy, France
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Fleury Sur Orne, France
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Gallardon, France
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Gelles, France
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La Motte Servolex, France
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Lambersart, France
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Le Bois D Oingt, France
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Le Bouscat, France
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Le Cannet, France
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Le Pontet, France
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Le Russey, France
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Lembach, France
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Marles Les Mines, France
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Marseille, France
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Mensignac, France
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Moreuil, France
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Mourmelon Le Petit, France
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Narbonne, France
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Neuilly Les Dijon, France
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Noyon, France
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Paris, France
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Pisany, France
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Puyricard, France
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Roissy En France, France
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Salles, France
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Sonchamp, France
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St Cyr Sur Loire, France
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St Esteve, France
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St Martin de Crau, France
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Ste Fortunade, France
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Ste Severe Sur Indre, France
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Toulon, France
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Villejuif, France
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Voisins Le Bretonneux, France
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Waziers, France
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Aiterhofen, Germany, 94330
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Bad Salzuflen, Germany, 32108
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Bergkamen, Germany, 59192
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Blankenhain, Germany, 99444
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Bockenem, Germany, 31167
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Deggingen, Germany, 73326
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Essen, Germany, 45279
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Gortringen, Germany, 71116
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Hamburg, Germany, 20354
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Koln, Germany, 51069
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Lengerich, Germany, 49525
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Lenne, Germany, 32584
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Ludwigshafen, Germany, 67067
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Offenbach, Germany, 63073
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Potsdam, Germany, 14482
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Reinfeld, Germany, 23858
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Remscheid, Germany, 42855
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Rodgau, Germany, 63110
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Spaichingen, Germany, 78549
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Stockach, Germany, 78333
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Wangen, Germany, 88239
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Wardenburg, Germany, 26203
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Weinheim, Germany, 69469
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Alexandroupolis, Greece
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Athens, Greece
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Drama, Greece
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Florina, Greece
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Heraklion, Greece
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Karditsa, Greece
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Kastoria, Greece
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Kozani, Greece
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Serres, Greece
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Thessaloniki, Greece
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Trikala, Greece
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Xanthi, Greece
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Salerno, Italy
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Varese, Italy
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Viareggio, Italy
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Amsterdam, Netherlands
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Andijk, Netherlands
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Bennebroek, Netherlands
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Den Haag, Netherlands
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Dordrecht, Netherlands
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Ermelo, Netherlands
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Lichtenvoorde, Netherlands
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Lieshout, Netherlands
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Losser, Netherlands
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Nijmegen, Netherlands
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Nijverdal, Netherlands
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Rijswijk, Netherlands
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Rilland-bath, Netherlands
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Roelofarendsveen, Netherlands
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Rotterdam, Netherlands
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Soerendonk, Netherlands
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Spijkenisse, Netherlands
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Volendam, Netherlands
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Woerden, Netherlands
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Arnes, Norway
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Baverbru, Norway
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Eydehavn, Norway
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Fornebu, Norway
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Frogner, Norway
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Hurdal, Norway
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Kirkenaer, Norway
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Lierskogen, Norway
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Lillestrom, Norway
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Mosterhamn, Norway
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Nordlenangen, Norway
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Oslo, Norway
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Rodal, Norway
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Skien, Norway
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Strommen, Norway
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Svelvik, Norway
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Tanager, Norway
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Campotejar, Spain
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Granada, Spain
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Huelva, Spain
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Malaga, Spain
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Nigran, Spain
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Tomino, Spain
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Vigo, Spain
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Dalby, Sweden
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Goteborg, Sweden
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Kristianstad, Sweden
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Lidingo, Sweden
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Limhamn, Sweden
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Pitee, Sweden
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Skanor, Sweden
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Stockholm, Sweden
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Vonnes, Sweden
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Ystad, Sweden
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Baden, Switzerland
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Basel, Switzerland
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Brittnau, Switzerland
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Buchs, Switzerland
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Chiasso, Switzerland
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Chur, Switzerland
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Egg bei Zurich, Switzerland
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Ilanz, Switzerland
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Oberwil, Switzerland
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Sarmenstorf, Switzerland
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Schiers, Switzerland
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St. Gallen, Switzerland
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Wallisellen, Switzerland
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Zurich, Switzerland
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?stanbul, Turkey
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?zmir, Turkey
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Ankara, Turkey
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Antalya, Turkey
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Ayd?n, Turkey
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Bursa, Turkey
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Diyarbak?r, Turkey
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Elaz??, Turkey
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Erzurum, Turkey
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Eski?ehir, Turkey
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Isparta, Turkey
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Kastamonu, Turkey
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Kayseri, Turkey
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Konya, Turkey
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Manisa, Turkey
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Trabzon, Turkey
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Van, Turkey
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Addlestone, Surrey, United Kingdom
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Ashford, Middlesex, United Kingdom
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Aston Clinton, Bucks, United Kingdom
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Atherstone, Warwickshire, United Kingdom
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Bangor, Northern Ireland, United Kingdom
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Bath, United Kingdom
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Belfast, United Kingdom
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Birmingham, United Kingdom
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Bradford-On-Avon, Wiltshire, United Kingdom
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Cookstown, Northern Ireland, United Kingdom
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Coventry, United Kingdom
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Crawley, West Sussex, United Kingdom
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Cumbernauld, United Kingdom
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Frome, Wiltshire, United Kingdom
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Glasgow, United Kingdom
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Harrow, Middlesex, United Kingdom
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High Valleyfield, Fife, United Kingdom
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Irvine, United Kingdom
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Leamington Spa, United Kingdom
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Maidenhead, United Kingdom
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Motherwell, United Kingdom
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New Stevenson, United Kingdom
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Newcastle-upon-Tyne, United Kingdom
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Pound Hill, Crawley, United Kingdom
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Randalstown, United Kingdom
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Sneinton, Nottingham, United Kingdom
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Stevenage, United Kingdom
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Titchfield, United Kingdom
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Trowbridge, United Kingdom
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Warminster, United Kingdom
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Watford, United Kingdom
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Wellingborough, United Kingdom
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Woolpit, Bury St Edmonds, United Kingdom
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients treated with NSAID therapy for diagnosed OA, RA or AS, and with GI risk factors. The patients will be asked to participate by their treating doctors at GP centres, specialist centres or hospitals.
Participating investigators will belong to a variety of centres representing the reality of how and where these patients are managed in each country.
Description
Inclusion Criteria:
- Diagnosis of arthritic disorder (osteoarthritis, rheumatoid arthritis or ankylosing spondylitis)
- Already receiving NSAID treatment at enrolment visit
Exclusion Criteria:
- Inability to complete the study related questionnaires
- Current participation in any interventional study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Adult patients treated with NSAID therapy for diagnosed OA, RA or AS, and with GI risk factors
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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The incidence of selected GI events, classified as "symptomatic" or "complicated" GI events. Reported by the patients at the follow-up visits.
Time Frame: Time from NSAID treatment prescription to first diagnosis of the GI event for each patient will be registered. Each patient will be followed up for 6 months.
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Time from NSAID treatment prescription to first diagnosis of the GI event for each patient will be registered. Each patient will be followed up for 6 months.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Number of health care visits and days of hospitalisation (health care consumption) related to arthritic disorder and/or GI events as reported by the patients at the follow-up visits.
Time Frame: Health care consumption accumulated over the 6 months study period will be registered.
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Health care consumption accumulated over the 6 months study period will be registered.
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Quality of life assessed by EuroQol-5 Dimension (EQ-5D) at baseline and the follow-up visits. Measure how selected GI events impact the EQ-5D score.
Time Frame: Measurements at baseline, 3 months and 6 months
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Measurements at baseline, 3 months and 6 months
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Adherence with NSAIDs and proton pump inhibitors (PPI) measured by Morisky-Green-Levine Medication Assessment Scale (MMAS) at baseline and follow-up visits.
Time Frame: Measurements at baseline, 3 months and 6 months
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Measurements at baseline, 3 months and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Javier Nuevo, MSc, Medical Department.AstraZeneca Spain
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
July 30, 2010
First Submitted That Met QC Criteria
August 5, 2010
First Posted (Estimate)
August 6, 2010
Study Record Updates
Last Update Posted (Estimate)
June 6, 2012
Last Update Submitted That Met QC Criteria
June 5, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Spinal Diseases
- Bone Diseases
- Spondylarthropathies
- Bone Diseases, Infectious
- Ankylosis
- Arthritis
- Arthritis, Rheumatoid
- Osteoarthritis
- Spondylitis
- Spondylarthritis
- Spondylitis, Ankylosing
Other Study ID Numbers
- NIS-GEU-DUM-2010/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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