Sprain of AnkleNCT00717119
Evaluation of the Effect of the Association of Proton Pump Inhibitor (PPIs) With Non-Steriodal Anti-Inflamatories (NSAIDs) in Work Leave Time.
An observational study of Sprain of Ankle, run by AstraZeneca at 1 site in Spain.
Trial summary
Retrospective cohort study to evaluate the effect of the association of PPIs with NSAIDs in work leave time. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sprain of Ankle
- How many people
- 6,356 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2008to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Data base of patients with work leave due to a sprain of ankle
Who may be able to join
- Work leave due to a sprain of ankle
Who cannot join
- (none)
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective cohort study to evaluate the effect of the association of PPIs with NSAIDs in work leave time.
- Conditions
- Sprain of Ankle
- Keywords
- GI, NSAID, Complications, Treated, Patients
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with sprain of ankle treated with NSAID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total work leave time
Measured: Jan 2007 to Dec 2007
Secondary outcomes (2)
GI complications
Measured: Jan 2007 to Dec 2007
Direct medical costs
Measured: Jan 2007 to Dec 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startApr 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sprain of AnkleStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,356 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ibermutuamur M.A.T.E.P.S
- Investigators
- Javier N Rivero, MSc, Study director, Epidemiology Unit. AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717119
- Sponsor's protocol ID
- NIS-GES-DUM-2008/3
- Status last verified
- Jul 2008
- First submitted
- 14 Jul 2008
- Last updated
- 15 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of the Association of Proton Pump Inhibitor (PPIs) With Non-Steriodal Anti-Inflamatories (NSAIDs) in Work Leave Time.
- ClinicalTrials.gov ID
- NCT00717119
- Acronym / sponsor ID
- NIS-GES-DUM-2008/3
- Conditions
- Sprain of Ankle
- Keywords
- GI, NSAID, Complications, Treated, Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,356 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Ibermutuamur M.A.T.E.P.S
- Study start
- Apr 2008
- Study completion
- Aug 2008 (actual)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective cohort study to evaluate the effect of the association of PPIs with NSAIDs in work leave time.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with sprain of ankle treated with NSAID |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Data base of patients with work leave due to a sprain of ankle
Key inclusion criteria (1 listed)
- Work leave due to a sprain of ankle
Key exclusion criteria (1 listed)
- (none)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total work leave time
Time frame: Jan 2007 to Dec 2007
2 secondary outcomes
GI complications
Time frame: Jan 2007 to Dec 2007
Direct medical costs
Time frame: Jan 2007 to Dec 2007
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier N Rivero, MSc study director
Epidemiology Unit. AstraZeneca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sprain of Ankle, run by AstraZeneca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total work leave time (time frame: Jan 2007 to Dec 2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2008.