Contact information
Type
Scientific
Primary contact
Dr Mary Newton
ORCID ID
Contact details
The National Hospital for Neurology and Neurosurgery
Queen Square
London
WC1N 3BG
United Kingdom
+44 (0)20 7829 8711
mary.newton@uclh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0263111551
Study information
Scientific title
Acronym
Study hypothesis
Does 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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Platelet dysfunction
Intervention
1. Rofecoxib
2. Diclofenac
This trial was stopped in September 2003 due to participant recruitment issues.
Intervention type
Drug
Phase
Not Specified
Drug names
Rofecoxib, diclofenac
Primary outcome measures
Assessment 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 measures
Not provided at time of registration
Overall trial start date
01/06/2002
Overall trial end date
01/09/2004
Reason abandoned
Participant recruitment issue
Eligibility
Participant inclusion criteria
30 Patients from Neurosurgery/NSITU.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
30
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/06/2002
Recruitment end date
01/09/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The National Hospital for Neurology and Neurosurgery
London
WC1N 3BG
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University College London Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary