Risk Factors Clinical Trial
— GADESOfficial title:
Compliance of Gastroprotection Treatment in the Prevention of Gastrointestinal Risk in Non-Steroidal Anti-inflammatory Drug (NSAID) Using Patients
| Verified date | December 2010 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Ethics Committee |
| Study type | Observational |
Prospective multicentric study to evaluate the compliance of gastroprotective treatment in NSAID patients at risk of GI complications. Secondary objectives: To identify the factors associated to treatment compliance (both NSAID and PPI), to evaluate the relationship between compliance and NSAID-associated GI events
| Status | Completed |
| Enrollment | 2000 |
| Est. completion date | January 2009 |
| Est. primary completion date | January 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Signed informed consent - Patients consulting to the specialized care clinics who have been prescribed NSAID and gastroprotection for at least 15 days following standard clinical practice. Exclusion Criteria: - Any gastroprotective treatment prescribed for other condition than NSAID-related gastrointestinal event prevention |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Spain | Research Site | A Coru?a | La Coru?a |
| Spain | Research Site | Alacant / Alicante | Alicante |
| Spain | Research Site | Albacete | |
| Spain | Research Site | Alcala de Henares | Madrid |
| Spain | Research Site | Alcoy | Alicante |
| Spain | Research Site | Algeciras | Cadiz |
| Spain | Research Site | Algemesi | Valencia |
| Spain | Research Site | Almeria | |
| Spain | Research Site | Almu?ecar | Granada |
| Spain | Research Site | Alzira | Valencia |
| Spain | Research Site | Aranjuez | Madrid |
| Spain | Research Site | Arona | Tenerife |
| Spain | Research Site | Avila | |
| Spain | Research Site | Badajoz | |
| Spain | Research Site | Badalona | Barcelona |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Bilbao | Vizcaya |
| Spain | Research Site | Bre?a Alta | Tenerife |
| Spain | Research Site | Burela | Lugo |
| Spain | Research Site | Burgos | |
| Spain | Research Site | Cabra | Cordoba |
| Spain | Research Site | Caceres | |
| Spain | Research Site | Cadiz | |
| Spain | Research Site | Calahorra | La Rioja |
| Spain | Research Site | Calatayud | Zaragoza |
| Spain | Research Site | Cartagena | Murcia |
| Spain | Research Site | Castelldefels | Barcelona |
| Spain | Research Site | Castellon de La Plana | Castellon |
| Spain | Research Site | Castilleja de La Cuesta | Sevilla |
| Spain | Research Site | Cieza | Murcia |
| Spain | Research Site | Cordoba | |
| Spain | Research Site | Coria | Caceres |
| Spain | Research Site | Cornella de Llobregat | Barcelona |
| Spain | Research Site | Cuenca | |
| Spain | Research Site | Don Benito | Badajoz |
| Spain | Research Site | El Ejido | Almeria |
| Spain | Research Site | El Hospitalet de Llobregat | Barcelona |
| Spain | Research Site | El Palmar (el Palmar) | Murcia |
| Spain | Research Site | El Puerto de Santa Maria | Cadiz |
| Spain | Research Site | Elcano | Navarra |
| Spain | Research Site | Elda | Alicante |
| Spain | Research Site | Elx / Elche | Alicante |
| Spain | Research Site | Estella/lizarra | Navarra |
| Spain | Research Site | Ferrol | La Coru?a |
| Spain | Research Site | Foz (casco Urbano) | Lugo |
| Spain | Research Site | Fuengirola | Malaga |
| Spain | Research Site | Galdakao | Vizcaya |
| Spain | Research Site | Getafe | Madrid |
| Spain | Research Site | Gijon | Asturias |
| Spain | Research Site | Granada | |
| Spain | Research Site | Granollers | Barcelona |
| Spain | Research Site | Guadalajara | |
| Spain | Research Site | Guadix | Granada |
| Spain | Research Site | Huelva | |
| Spain | Research Site | Huercal Overa | Almeria |
| Spain | Research Site | Jaen | |
| Spain | Research Site | Jerez de La Frontera | Cadiz |
| Spain | Research Site | La Laguna | Tenerife |
| Spain | Research Site | La Orotava | Tenerife |
| Spain | Research Site | La/villajoyosa Vila Joiosa | Alicante |
| Spain | Research Site | Las Palmas de Gran Canaria | Las Palmas |
| Spain | Research Site | Leganes | Madrid |
| Spain | Research Site | Leon | |
| Spain | Research Site | Linares | Jaen |
| Spain | Research Site | Lleida | Lerida |
| Spain | Research Site | Logro?o | La Rioja |
| Spain | Research Site | Lugo | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Majadahonda | Madrid |
| Spain | Research Site | Malaga | |
| Spain | Research Site | Manacor | Baleares |
| Spain | Research Site | Manresa | Barcelona |
| Spain | Research Site | Marbella | Malaga |
| Spain | Research Site | Martorell | Barcelona |
| Spain | Research Site | Melilla | |
| Spain | Research Site | Mendaro | Guipuzcoa |
| Spain | Research Site | Monforte (casco Urbano) | Lugo |
| Spain | Research Site | Mostoles | Madrid |
| Spain | Research Site | Motril | Granada |
| Spain | Research Site | Murcia | |
| Spain | Research Site | Murias (mieres) | Asturias |
| Spain | Research Site | Navalmoral de La Mata | Caceres |
| Spain | Research Site | Oleiros (ribeira) | La Coru?a |
| Spain | Research Site | Orense | |
| Spain | Research Site | Orihuela | Alicante |
| Spain | Research Site | Oviedo | Asturias |
| Spain | Research Site | Palma de Mallorca | Baleares |
| Spain | Research Site | Pamplona | Navarra |
| Spain | Research Site | Plasencia | Caceres |
| Spain | Research Site | Pontevedra | |
| Spain | Research Site | Puente Genil | Cordoba |
| Spain | Research Site | Puerto de Sagunto | Valencia |
| Spain | Research Site | Puerto Del Rosario | Las Palmas |
| Spain | Research Site | Puertollano | Ciudad Real |
| Spain | Research Site | Requena | Valencia |
| Spain | Research Site | Ria?o (langreo) | Asturias |
| Spain | Research Site | Sabadell | Barcelona |
| Spain | Research Site | San Bartolome | Alicante |
| Spain | Research Site | San Lorenzo de El Escorial | Madrid |
| Spain | Research Site | Sant Boi de Llobregat | Barcelona |
| Spain | Research Site | Sant Vicent Del Raspeig | Alicante |
| Spain | Research Site | Santa Cruz de Tenerife | Tenerife |
| Spain | Research Site | Santiago de Compostela | La Coru?a |
| Spain | Research Site | Santiago de La Ribera | Murcia |
| Spain | Research Site | Sevilla | |
| Spain | Research Site | Sueca | Valencia |
| Spain | Research Site | Talavera de La Reina | Toledo |
| Spain | Research Site | Tarragona | |
| Spain | Research Site | Telde | Las Palmas |
| Spain | Research Site | Toledo | |
| Spain | Research Site | Tolosa | Guipuzcoa |
| Spain | Research Site | Torrebonica | Barcelona |
| Spain | Research Site | Torrelavega | Cantabria |
| Spain | Research Site | Torrent | Valencia |
| Spain | Research Site | Tudela | Navarra |
| Spain | Research Site | Ubeda | Jaen |
| Spain | Research Site | Valdepe?as | Ciudad Real |
| Spain | Research Site | Valencia | |
| Spain | Research Site | Verin | Orense |
| Spain | Research Site | Vigo | Pontevedra |
| Spain | Research Site | Viladecans | Barcelona |
| Spain | Research Site | Vilagarcia de Arousa | Pontevedra |
| Spain | Research Site | Vinaros | Castellon |
| Spain | Research Site | Vitoria | Alava |
| Spain | Research Site | Xativa | Valencia |
| Spain | Research Site | Zafra | Badajoz |
| Spain | Research Site | Zamora | |
| Spain | Research Site | Zaragoza |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adherence to gastroprotection treatment | End of follow-up (3-5 weeks) | No | |
| Secondary | Identify factors associated with treatment compliance | End of follow-up | No | |
| Secondary | Evaluate the relationship among GI events and treatment compliance | End of follow-up | No |
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