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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 16, 2014