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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00699725
First received: June 17, 2008
Last updated: December 6, 2010
Last verified: December 2010
  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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identify factors associated with treatment compliance [ Time Frame: End of follow-up ] [ Designated as safety issue: No ]
  • Evaluate the relationship among GI events and treatment compliance [ Time Frame: End of follow-up ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699725

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

No publications provided

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
Study First Received: June 17, 2008
Last Updated: December 6, 2010
Health Authority: Spain: Ethics Committee

Keywords provided by AstraZeneca:
Compliance
gastroprotector therapy
NSAID
risk factors

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

ClinicalTrials.gov processed this record on April 17, 2014