Condition category
Haematological Disorders
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
19/07/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes