Evaluation of the Effect of the Association of Proton Pump Inhibitor (PPIs) With Non-Steriodal Anti-Inflamatories (NSAIDs) in Work Leave Time.

This study has been completed.

First Received: July 14, 2008 Last Updated: September 12, 2008 History of Changes

Sponsors and Collaborators:	AstraZeneca Ibermutuamur M.A.T.E.P.S
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00717119

Purpose

Retrospective cohort study to evaluate the effect of the association of PPIs with NSAIDs in work leave time.

Condition
Sprain of Ankle

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Evaluation of the Effect of the Association of Proton Pump Inhibitor (PPIs) With Non-Steriodal Anti-Inflamatories (NSAIDs) in Work Leave Time.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Total work leave time [ Time Frame: Jan 2007 to Dec 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

GI complications [ Time Frame: Jan 2007 to Dec 2007 ] [ Designated as safety issue: No ]
Direct medical costs [ Time Frame: Jan 2007 to Dec 2007 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	6356
Study Start Date:	April 2008
Study Completion Date:	August 2008

Groups/Cohorts
1 Patients with sprain of ankle treated with NSAID

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Data base of patients with work leave due to a sprain of ankle

Criteria

Inclusion Criteria:

Work leave due to a sprain of ankle

Exclusion Criteria:

(none)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717119

Locations

Spain
Research Site
Madrid, Spain

Sponsors and Collaborators

AstraZeneca

Ibermutuamur M.A.T.E.P.S

Investigators

Study Director:

Javier N Rivero, MSc

Epidemiology Unit. AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Mónica Tafalla/MD, PhD )
Study ID Numbers:	NIS-GES-DUM-2008/3
Study First Received:	July 14, 2008
Last Updated:	September 12, 2008
ClinicalTrials.gov Identifier:	NCT00717119 History of Changes
Health Authority:	Spain: Ethics Committee

Keywords provided by AstraZeneca:

GI
NSAID
Complications
Treated
Patients

Study placed in the following topic categories:

Anti-Inflammatory Agents
Proton Pump Inhibitors
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Proton Pump Inhibitors
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009