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

Sprain of Ankle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717119
• Other study ID #: NIS-GES-DUM-2008/3
• Status: Completed
• Phase: N/A
• First received: July 14, 2008
• Last updated: September 12, 2008
• Start date: April 2008
• Est. completion date: August 2008

Study information

• Verified date: July 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6356
• Est. completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Work leave due to a sprain of ankle

Exclusion Criteria:

• (none)

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Sprain of Ankle

Locations

Country	Name	City	State
Spain	Research Site	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Ibermutuamur M.A.T.E.P.S

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total work leave time		Jan 2007 to Dec 2007	No
Secondary	GI complications		Jan 2007 to Dec 2007	No
Secondary	Direct medical costs		Jan 2007 to Dec 2007	No