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.
Sponsor:
Collaborator:
Ibermutuamur M.A.T.E.P.S
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00717119
First received: July 14, 2008
Last updated: September 12, 2008
Last verified: July 2008
  Purpose

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


Condition
Sprain of Ankle

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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 ]

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

Keywords provided by AstraZeneca:
GI
NSAID
Complications
Treated
Patients

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries
Anti-Inflammatory Agents, Non-Steroidal
Proton Pump Inhibitors
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014