A comparison of the effects of rofecoxib and diclofenac on the PFA-100, a laboratory based indicator of platelet function, in a post-operative neurosurgical population

ISRCTN ISRCTN73370863
DOI https://doi.org/10.1186/ISRCTN73370863
Secondary identifying numbers N0263111551
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
19/07/2012
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mary Newton
Scientific

The National Hospital for Neurology and Neurosurgery
Queen Square
London
WC1N 3BG
United Kingdom

Phone +44 (0)20 7829 8711
Email mary.newton@uclh.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesDoes rofecoxib, a non-steroidal COX II inhibitor analgesic, cause less platelet dysfunction than diclofenac, a standard non-steroidal COX I inhibitor, in post-operative neurosurgical patients when used as analgesic adjuncts?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPlatelet dysfunction
Intervention1. Rofecoxib
2. Diclofenac

This trial was stopped in September 2003 due to participant recruitment issues.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Rofecoxib, diclofenac
Primary outcome measureAssessment of comparative effects of COX I/COX II inhibitors on platelet function using the platelet function analyser, the PFA-100, on blood samples taken from the participants.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/06/2002
Completion date01/09/2004
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants30
Key inclusion criteria30 Patients from Neurosurgery/NSITU.
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/06/2002
Date of final enrolment01/09/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The National Hospital for Neurology and Neurosurgery
London
WC1N 3BG
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

University College London Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan