Adherence to Gastro-Protection in Non-Steroidal Anti-Inflammatory Drug (NSAID) Using Patients - Full Text View

Adherence to Gastro-Protection in Non-Steroidal Anti-Inflammatory Drug (NSAID) Using Patients (GADES)

This study has been completed.

First Received: June 17, 2008 Last Updated: February 9, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00699725

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:	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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2000
Study Start Date:	May 2008
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:	AstraZeneca Pharmaceuticals ( Mercedes Muñoz, PhD, Local MC GI Therapeutic Area Manager )
Study ID Numbers:	NIS-GES-DUM-2008/2
Study First Received:	June 17, 2008
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00699725 History of Changes
Health Authority:	Spain: Ethics Committee

Keywords provided by AstraZeneca:

Compliance
gastroprotector therapy
NSAID
risk factors

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs

Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010