Adherence to Gastro-protection in Non-steroidal Anti-inflammatory Drug (NSAID) Using Patients (GADES)

December 6, 2010 updated by: AstraZeneca

Compliance of Gastroprotection Treatment in the Prevention of Gastrointestinal Risk in Non-Steroidal Anti-inflammatory Drug (NSAID) Using Patients

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

2000

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

  • Spain
      • Albacete, Spain
        • Research Site
      • Almeria, Spain
        • Research Site
      • Avila, Spain
        • Research Site
      • Badajoz, Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Burgos, Spain
        • Research Site
      • Caceres, Spain
        • Research Site
      • Cadiz, Spain
        • Research Site
      • Cordoba, Spain
        • Research Site
      • Cuenca, Spain
        • Research Site
      • Granada, Spain
        • Research Site
      • Guadalajara, Spain
        • Research Site
      • Huelva, Spain
        • Research Site
      • Jaen, Spain
        • Research Site
      • Leon, Spain
        • Research Site
      • Lugo, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Malaga, Spain
        • Research Site
      • Melilla, Spain
        • Research Site
      • Murcia, Spain
        • Research Site
      • Orense, Spain
        • Research Site
      • Pontevedra, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Tarragona, Spain
        • Research Site
      • Toledo, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
      • Zamora, Spain
        • Research Site
      • Zaragoza, Spain
        • Research Site
    • Alava
      • Vitoria, Alava, Spain
        • Research Site
    • Alicante
      • Alacant / Alicante, Alicante, Spain
        • Research Site
      • Alcoy, Alicante, Spain
        • Research Site
      • Elda, Alicante, Spain
        • Research Site
      • Elx / Elche, Alicante, Spain
        • Research Site
      • La/villajoyosa Vila Joiosa, Alicante, Spain
        • Research Site
      • Orihuela, Alicante, Spain
        • Research Site
      • San Bartolome, Alicante, Spain
        • Research Site
      • Sant Vicent Del Raspeig, Alicante, Spain
        • Research Site
    • Almeria
      • El Ejido, Almeria, Spain
        • Research Site
      • Huercal Overa, Almeria, Spain
        • Research Site
    • Asturias
      • Gijon, Asturias, Spain
        • Research Site
      • Murias (mieres), Asturias, Spain
        • Research Site
      • Oviedo, Asturias, Spain
        • Research Site
      • Ria�o (langreo), Asturias, Spain
        • Research Site
    • Badajoz
      • Don Benito, Badajoz, Spain
        • Research Site
      • Zafra, Badajoz, Spain
        • Research Site
    • Baleares
      • Manacor, Baleares, Spain
        • Research Site
      • Palma de Mallorca, Baleares, Spain
        • Research Site
    • Barcelona
      • Badalona, Barcelona, Spain
        • Research Site
      • Castelldefels, Barcelona, Spain
        • Research Site
      • Cornella de Llobregat, Barcelona, Spain
        • Research Site
      • El Hospitalet de Llobregat, Barcelona, Spain
        • Research Site
      • Granollers, Barcelona, Spain
        • Research Site
      • Manresa, Barcelona, Spain
        • Research Site
      • Martorell, Barcelona, Spain
        • Research Site
      • Sabadell, Barcelona, Spain
        • Research Site
      • Sant Boi de Llobregat, Barcelona, Spain
        • Research Site
      • Torrebonica, Barcelona, Spain
        • Research Site
      • Viladecans, Barcelona, Spain
        • Research Site
    • Caceres
      • Coria, Caceres, Spain
        • Research Site
      • Navalmoral de La Mata, Caceres, Spain
        • Research Site
      • Plasencia, Caceres, Spain
        • Research Site
    • Cadiz
      • Algeciras, Cadiz, Spain
        • Research Site
      • El Puerto de Santa Maria, Cadiz, Spain
        • Research Site
      • Jerez de La Frontera, Cadiz, Spain
        • Research Site
    • Cantabria
      • Torrelavega, Cantabria, Spain
        • Research Site
    • Castellon
      • Castellon de La Plana, Castellon, Spain
        • Research Site
      • Vinaros, Castellon, Spain
        • Research Site
    • Ciudad Real
      • Puertollano, Ciudad Real, Spain
        • Research Site
      • Valdepe�as, Ciudad Real, Spain
        • Research Site
    • Cordoba
      • Cabra, Cordoba, Spain
        • Research Site
      • Puente Genil, Cordoba, Spain
        • Research Site
    • Granada
      • Almu�ecar, Granada, Spain
        • Research Site
      • Guadix, Granada, Spain
        • Research Site
      • Motril, Granada, Spain
        • Research Site
    • Guipuzcoa
      • Mendaro, Guipuzcoa, Spain
        • Research Site
      • Tolosa, Guipuzcoa, Spain
        • Research Site
    • Jaen
      • Linares, Jaen, Spain
        • Research Site
      • Ubeda, Jaen, Spain
        • Research Site
    • La Coru�a
      • A Coru�a, La Coru�a, Spain
        • Research Site
      • Ferrol, La Coru�a, Spain
        • Research Site
      • Oleiros (ribeira), La Coru�a, Spain
        • Research Site
      • Santiago de Compostela, La Coru�a, Spain
        • Research Site
    • La Rioja
      • Calahorra, La Rioja, Spain
        • Research Site
      • Logro�o, La Rioja, Spain
        • Research Site
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain
        • Research Site
      • Puerto Del Rosario, Las Palmas, Spain
        • Research Site
      • Telde, Las Palmas, Spain
        • Research Site
    • Lerida
      • Lleida, Lerida, Spain
        • Research Site
    • Lugo
      • Burela, Lugo, Spain
        • Research Site
      • Foz (casco Urbano), Lugo, Spain
        • Research Site
      • Monforte (casco Urbano), Lugo, Spain
        • Research Site
    • Madrid
      • Alcala de Henares, Madrid, Spain
        • Research Site
      • Aranjuez, Madrid, Spain
        • Research Site
      • Getafe, Madrid, Spain
        • Research Site
      • Leganes, Madrid, Spain
        • Research Site
      • Majadahonda, Madrid, Spain
        • Research Site
      • Mostoles, Madrid, Spain
        • Research Site
      • San Lorenzo de El Escorial, Madrid, Spain
        • Research Site
    • Malaga
      • Fuengirola, Malaga, Spain
        • Research Site
      • Marbella, Malaga, Spain
        • Research Site
    • Murcia
      • Cartagena, Murcia, Spain
        • Research Site
      • Cieza, Murcia, Spain
        • Research Site
      • El Palmar (el Palmar), Murcia, Spain
        • Research Site
      • Santiago de La Ribera, Murcia, Spain
        • Research Site
    • Navarra
      • Elcano, Navarra, Spain
        • Research Site
      • Estella/lizarra, Navarra, Spain
        • Research Site
      • Pamplona, Navarra, Spain
        • Research Site
      • Tudela, Navarra, Spain
        • Research Site
    • Orense
      • Verin, Orense, Spain
        • Research Site
    • Pontevedra
      • Vigo, Pontevedra, Spain
        • Research Site
      • Vilagarcia de Arousa, Pontevedra, Spain
        • Research Site
    • Sevilla
      • Castilleja de La Cuesta, Sevilla, Spain
        • Research Site
    • Tenerife
      • Arona, Tenerife, Spain
        • Research Site
      • Bre�a Alta, Tenerife, Spain
        • Research Site
      • La Laguna, Tenerife, Spain
        • Research Site
      • La Orotava, Tenerife, Spain
        • Research Site
      • Santa Cruz de Tenerife, Tenerife, Spain
        • Research Site
    • Toledo
      • Talavera de La Reina, Toledo, Spain
        • Research Site
    • Valencia
      • Algemesi, Valencia, Spain
        • Research Site
      • Alzira, Valencia, Spain
        • Research Site
      • Puerto de Sagunto, Valencia, Spain
        • Research Site
      • Requena, Valencia, Spain
        • Research Site
      • Sueca, Valencia, Spain
        • Research Site
      • Torrent, Valencia, Spain
        • Research Site
      • Xativa, Valencia, Spain
        • Research Site
    • Vizcaya
      • Bilbao, Vizcaya, Spain
        • Research Site
      • Galdakao, Vizcaya, Spain
        • Research Site
    • Zaragoza
      • Calatayud, Zaragoza, Spain
        • Research Site

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

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

Cohorts and Interventions

Group / Cohort
1
NSAID patients with risk factors treated with gastroprotective drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adherence to gastroprotection treatment
Time Frame: End of follow-up (3-5 weeks)
End of follow-up (3-5 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Identify factors associated with treatment compliance
Time Frame: End of follow-up
End of follow-up
Evaluate the relationship among GI events and treatment compliance
Time Frame: End of follow-up
End of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Chair: Javier Zapardiel, AstraZeneca Spain Medical Dept

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

May 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

June 17, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Estimate)

December 7, 2010

Last Update Submitted That Met QC Criteria

December 6, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NIS-GES-DUM-2008/2

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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