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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00699725
First Posted: June 18, 2008
Last Update Posted: December 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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

Condition
Compliance Gastroprotector Therapy Risk Factors

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Compliance of Gastroprotection Treatment in the Prevention of Gastrointestinal Risk in Non-Steroidal Anti-inflammatory Drug (NSAID) Using Patients

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adherence to gastroprotection treatment [ Time Frame: End of follow-up (3-5 weeks) ]

Secondary Outcome Measures:
  • Identify factors associated with treatment compliance [ Time Frame: End of follow-up ]
  • Evaluate the relationship among GI events and treatment compliance [ Time Frame: End of follow-up ]

Estimated Enrollment: 2000
Study Start Date: May 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
NSAID patients with risk factors treated with gastroprotective drugs

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699725


  Show 128 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Javier Zapardiel AstraZeneca Spain Medical Dept
  More Information

Responsible Party: Mercedes Muñoz, PhD, Local MC GI Therapeutic Area Manager, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00699725     History of Changes
Other Study ID Numbers: NIS-GES-DUM-2008/2
First Submitted: June 17, 2008
First Posted: June 18, 2008
Last Update Posted: December 7, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Compliance
gastroprotector therapy
NSAID
risk factors

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents