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
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: 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 July 23, 2014