Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
03/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Penelope Shirlaw

ORCID ID

Contact details

Oral Medicine Department
22nd Floor
Guy's Tower
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom
+44 (0)20 7188 4399
pepe.shirlaw@gstt.sthames.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013129667

Study information

Scientific title

Acronym

Study hypothesis

The study is designed to decide whether the COX-2 specific non-steroidal anti-inflammatory drug rofecoxib is effective in the relief of pain in patients with acute upper and lower limb injuries.

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

Other

Patient information sheet

Condition

Pain, lower leg injury

Intervention

Patients will be randomised to receive either rofecoxib or diclofenac at the triage area. They will have regular objective and subjective pain and functional assessments and will be treated in the department (as per normal). They will receive the study drugs for a further 5 days, with ongoing assessments.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The main outcome measure is the change in VAS score over time after the initial dose of study medication over the next 4 hours.

Secondary outcome measures

Secondary outcome measures are twice daily patient's global assessments of pain and VAS score. There will be a modified SF-36 to complete on day 5.

Overall trial start date

19/06/2003

Overall trial end date

19/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients presenting to the emergency department with acute lower limb injuries. These must be less than 48 hours old and only include non-penetrating injuries with a pain score of 40 mm or more on a 100 mm Visual Analogue Scale (VAS).

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

19/06/2003

Recruitment end date

19/12/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oral Medicine Department
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Guy's and St Thomas' 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

1. 2006 results in 'Leading Abstracts of the Third Mediterranean Emergency Medicine Congress, Nice, France; September 1-5 2005' http://journals.lww.com/euro-emergencymed/Fulltext/2006/02000/Abstract_44_Utility_of_a_Cox_2_specific.18.aspx

Publication citations

Additional files

Editorial Notes