Clinical trial NCT00699725: Adherence to Gastro-protection in Non-steroidal Anti-inflammatory Drug (NSAID) Using Patients
Official title: Compliance of Gastroprotection Treatment in the Prevention of Gastrointestinal Risk in Non-Steroidal Anti-inflammatory Drug (NSAID) Using Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Compliance
Gastroprotector Therapy
Risk Factors
Keywords: Compliance
gastroprotector therapy
NSAID
risk factors
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending secondary care clinics who are prescribed NSAID and gastroprotection for at least 15 days following standard clinical practice.

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Adherence to gastroprotection treatment
timeFrame: End of follow-up (3-5 weeks)
Secondary outcomes:
measure: Identify factors associated with treatment compliance
timeFrame: End of follow-up
measure: Evaluate the relationship among GI events and treatment compliance
timeFrame: End of follow-up
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Research Site
state: Alava
city: Alacant / Alicante
country: Spain
facility: Research Site
state: Alicante
city: Alcoy
country: Spain
facility: Research Site
state: Alicante
city: Elda
country: Spain
facility: Research Site
state: Alicante
city: Elx / Elche
country: Spain
facility: Research Site
state: Alicante
city: La/villajoyosa Vila Joiosa
country: Spain
facility: Research Site
state: Alicante
city: Orihuela
country: Spain
facility: Research Site
state: Alicante
city: San Bartolome
country: Spain
facility: Research Site
state: Alicante
city: Sant Vicent Del Raspeig
country: Spain
facility: Research Site
state: Alicante
city: El Ejido
country: Spain
facility: Research Site
state: Almeria
city: Huercal Overa
country: Spain
facility: Research Site
state: Almeria
city: Gijon
country: Spain
facility: Research Site
state: Asturias
city: Murias (mieres)
country: Spain
facility: Research Site
state: Asturias
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Ria�o (langreo)
country: Spain
facility: Research Site
state: Asturias
city: Don Benito
country: Spain
facility: Research Site
state: Badajoz
city: Zafra
country: Spain
facility: Research Site
state: Badajoz
city: Manacor
country: Spain
facility: Research Site
state: Baleares
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Baleares
city: Badalona
country: Spain
facility: Research Site
state: Barcelona
city: Castelldefels
country: Spain
facility: Research Site
state: Barcelona
city: Cornella de Llobregat
country: Spain
facility: Research Site
state: Barcelona
city: El Hospitalet de Llobregat
country: Spain
facility: Research Site
state: Barcelona
city: Granollers
country: Spain
facility: Research Site
state: Barcelona
city: Manresa
country: Spain
facility: Research Site
state: Barcelona
city: Martorell
country: Spain
facility: Research Site
state: Barcelona
city: Sabadell
country: Spain
facility: Research Site
state: Barcelona
city: Sant Boi de Llobregat
country: Spain
facility: Research Site
state: Barcelona
city: Torrebonica
country: Spain
facility: Research Site
state: Barcelona
city: Viladecans
country: Spain
facility: Research Site
state: Barcelona
city: Coria
country: Spain
facility: Research Site
state: Caceres
city: Navalmoral de La Mata
country: Spain
facility: Research Site
state: Caceres
city: Plasencia
country: Spain
facility: Research Site
state: Caceres
city: Algeciras
country: Spain
facility: Research Site
state: Cadiz
city: El Puerto de Santa Maria
country: Spain
facility: Research Site
state: Cadiz
city: Jerez de La Frontera
country: Spain
facility: Research Site
state: Cadiz
city: Torrelavega
country: Spain
facility: Research Site
state: Cantabria
city: Castellon de La Plana
country: Spain
facility: Research Site
state: Castellon
city: Vinaros
country: Spain
facility: Research Site
state: Castellon
city: Puertollano
country: Spain
facility: Research Site
state: Ciudad Real
city: Valdepe�as
country: Spain
facility: Research Site
state: Ciudad Real
city: Cabra
country: Spain
facility: Research Site
state: Cordoba
city: Puente Genil
country: Spain
facility: Research Site
state: Cordoba
city: Almu�ecar
country: Spain
facility: Research Site
state: Granada
city: Guadix
country: Spain
facility: Research Site
state: Granada
city: Motril
country: Spain
facility: Research Site
state: Granada
city: Mendaro
country: Spain
facility: Research Site
state: Guipuzcoa
city: Tolosa
country: Spain
facility: Research Site
state: Guipuzcoa
city: Linares
country: Spain
facility: Research Site
state: Jaen
city: Ubeda
country: Spain
facility: Research Site
state: Jaen
city: A Coru�a
country: Spain
facility: Research Site
state: La Coru�a
city: Ferrol
country: Spain
facility: Research Site
state: La Coru�a
city: Oleiros (ribeira)
country: Spain
facility: Research Site
state: La Coru�a
city: Santiago de Compostela
country: Spain
facility: Research Site
state: La Coru�a
city: Calahorra
country: Spain
facility: Research Site
state: La Rioja
city: Logro�o
country: Spain
facility: Research Site
state: La Rioja
city: Las Palmas de Gran Canaria
country: Spain
facility: Research Site
state: Las Palmas
city: Puerto Del Rosario
country: Spain
facility: Research Site
state: Las Palmas
city: Telde
country: Spain
facility: Research Site
state: Las Palmas
city: Lleida
country: Spain
facility: Research Site
state: Lerida
city: Burela
country: Spain
facility: Research Site
state: Lugo
city: Foz (casco Urbano)
country: Spain
facility: Research Site
state: Lugo
city: Monforte (casco Urbano)
country: Spain
facility: Research Site
state: Lugo
city: Alcala de Henares
country: Spain
facility: Research Site
state: Madrid
city: Aranjuez
country: Spain
facility: Research Site
state: Madrid
city: Getafe
country: Spain
facility: Research Site
state: Madrid
city: Leganes
country: Spain
facility: Research Site
state: Madrid
city: Majadahonda
country: Spain
facility: Research Site
state: Madrid
city: Mostoles
country: Spain
facility: Research Site
state: Madrid
city: San Lorenzo de El Escorial
country: Spain
facility: Research Site
state: Madrid
city: Fuengirola
country: Spain
facility: Research Site
state: Malaga
city: Marbella
country: Spain
facility: Research Site
state: Malaga
city: Cartagena
country: Spain
facility: Research Site
state: Murcia
city: Cieza
country: Spain
facility: Research Site
state: Murcia
city: El Palmar (el Palmar)
country: Spain
facility: Research Site
state: Murcia
city: Santiago de La Ribera
country: Spain
facility: Research Site
state: Murcia
city: Elcano
country: Spain
facility: Research Site
state: Navarra
city: Estella/lizarra
country: Spain
facility: Research Site
state: Navarra
city: Pamplona
country: Spain
facility: Research Site
state: Navarra
city: Tudela
country: Spain
facility: Research Site
state: Navarra
city: Verin
country: Spain
facility: Research Site
state: Orense
city: Vigo
country: Spain
facility: Research Site
state: Pontevedra
city: Vilagarcia de Arousa
country: Spain
facility: Research Site
state: Pontevedra
city: Castilleja de La Cuesta
country: Spain
facility: Research Site
state: Sevilla
city: Arona
country: Spain
facility: Research Site
state: Tenerife
city: Bre�a Alta
country: Spain
facility: Research Site
state: Tenerife
city: La Laguna
country: Spain
facility: Research Site
state: Tenerife
city: La Orotava
country: Spain
facility: Research Site
state: Tenerife
city: Santa Cruz de Tenerife
country: Spain
facility: Research Site
state: Tenerife
city: Talavera de La Reina
country: Spain
facility: Research Site
state: Toledo
city: Algemesi
country: Spain
facility: Research Site
state: Valencia
city: Alzira
country: Spain
facility: Research Site
state: Valencia
city: Puerto de Sagunto
country: Spain
facility: Research Site
state: Valencia
city: Requena
country: Spain
facility: Research Site
state: Valencia
city: Sueca
country: Spain
facility: Research Site
state: Valencia
city: Torrent
country: Spain
facility: Research Site
state: Valencia
city: Xativa
country: Spain
facility: Research Site
state: Valencia
city: Bilbao
country: Spain
facility: Research Site
state: Vizcaya
city: Galdakao
country: Spain
facility: Research Site
state: Vizcaya
city: Calatayud
country: Spain
facility: Research Site
state: Zaragoza
city: Albacete
country: Spain
facility: Research Site
city: Almeria
country: Spain
facility: Research Site
city: Avila
country: Spain
facility: Research Site
city: Badajoz
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Burgos
country: Spain
facility: Research Site
city: Caceres
country: Spain
facility: Research Site
city: Cadiz
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Cuenca
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Guadalajara
country: Spain
facility: Research Site
city: Huelva
country: Spain
facility: Research Site
city: Jaen
country: Spain
facility: Research Site
city: Leon
country: Spain
facility: Research Site
city: Lugo
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Melilla
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Orense
country: Spain
facility: Research Site
city: Pontevedra
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Tarragona
country: Spain
facility: Research Site
city: Toledo
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Zamora
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
Study officials:
affiliation: AstraZeneca Spain Medical Dept
name: Javier Zapardiel
role: STUDY_CHAIR
References: