NCT02688504 (CESIR-U2) is a clinical trial in Car Accident, sponsored by University Hospital, Bordeaux.

Who is sponsoring NCT02688504?

NCT02688504 is sponsored by University Hospital, Bordeaux.

What condition does NCT02688504 study?

NCT02688504 studies Car Accident.

Is NCT02688504 still recruiting?

NCT02688504 is currently completed. Last updated 14 May 2020.

Last reviewed 2020-05-14 · How we verify

NCT02688504: CESIR-U2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Health and Road Safety: Influence of Drugs Use and Health Status

Completed Last updated 14 May 2020

What this trial tests

trial in Car Accident in 1,200 participants. Completed in 26 December 2018.

Timeline

18 October 2016

Primary endpoint
26 December 2018

26 December 2018

Quick facts

Lead sponsor	University Hospital, Bordeaux
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,200
Start date	18 October 2016
Primary completion	26 December 2018
Estimated completion	26 December 2018
Sites	2 locations across France

Conditions studied

Car Accident — all drugs for Car Accident →

Sponsor

University Hospital, Bordeaux

Who can join

18 and older, any sex, with Car Accident. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In France, drugs affecting driving ability directly or by indicating at-risk diseases are classified in a 4-level standardized classification associated with a graded pictogram. When the French authorities required this graded pictogram, they commissioned the CESIR-U1 study, a study designed to describe the use of labelled medicines by drivers involved in serious road accidents (hospitalization \> 24h). This study, conducted in Bordeaux, Limoges and Toulouse, recruited 679 drivers involved in serious road accidents. When the responsibility of the driver is taken into account, it appears that the association of risk factors (alcohol, sleep, ...) and the use of labelled drugs increases this responsibility. Even though labelled medicines seemed slightly more at risk than unlabelled ones, this did not reach significance. This conclusion is different from the conclusion of CESIR-A, a data linkage study of the police and the health insurance databases which showed a correlation between the use of grade 2 or 3 labelled medicines and driver responsibility. This difference between CESIR-U and CESIR-A could be related to a lack of power or to the characteristics of the subjects included (mostly young men and motorcycle drivers). That is why it was thought interesting to increase the size of the sample and to include non serious road accidents (hospitalization \< 24 hours) that represent around 73% of accidents.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02688504 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital, Bordeaux
Last refreshed: 14 May 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02688504.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing