NCT00717119

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,356

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

September 15, 2008

Status Verified

July 1, 2008

First QC Date

July 14, 2008

Last Update Submit

September 12, 2008

Conditions

Sprain of Ankle

Keywords

GINSAIDComplicationsTreatedPatients

Outcome Measures

Primary Outcomes (1)

  • Total work leave time

    Jan 2007 to Dec 2007

Secondary Outcomes (2)

  • GI complications

    Jan 2007 to Dec 2007

  • Direct medical costs

    Jan 2007 to Dec 2007

Study Arms (1)

1

Patients with sprain of ankle treated with NSAID

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Work leave due to a sprain of ankle

You may not qualify if:

  • (none)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Madrid, Spain

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Javier N Rivero, MSc

    Epidemiology Unit. AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 14, 2008

First Posted

July 16, 2008

Study Start

April 1, 2008

Study Completion

August 1, 2008

Last Updated

September 15, 2008

Record last verified: 2008-07

Locations

ES(1)