Randomised placebo controlled cross-over trial of topical opioids in the management of analgesia in leg ulcers

ISRCTN ISRCTN76288165
DOI https://doi.org/10.1186/ISRCTN76288165
Secondary identifying numbers N0295122854
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
14/10/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
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 Joanne Deacon
Scientific

Department of Dermatology
UHCW NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomised placebo controlled cross-over trial of topical opioids in the management of analgesia in leg ulcers
Study objectivesDoes topical morphine reduce the systematic requirement for analgesia in the treatment of pain from chronic leg ulcers?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSigns and Symptoms: Pain
InterventionProspective randomised controlled cross-over trial with questionnaire and interviews. Topical opioids versus placebo.
Intervention typeOther
Primary outcome measurePRN (pro re nata - as needed) and regular analgesia requirement over preceding 24 h. Daily pain score and questionnaire regarding side-effects.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/06/2003
Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants20
Key inclusion criteria20 Patients with chronic painful leg ulcers, from all inpatients at the Walsgrave Hospital (powered to give 75-80% preference rate of either active or placebo gel).
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/06/2003
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Dermatology
Coventry
CV2 2DX
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 Hospitals Coventry and Warwickshire 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