Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0295122854
Study information
Scientific title
Randomised placebo controlled cross-over trial of topical opioids in the management of analgesia in leg ulcers
Acronym
Study hypothesis
Does topical morphine reduce the systematic requirement for analgesia in the treatment of pain from chronic leg ulcers?
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
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Signs and Symptoms: Pain
Intervention
Prospective randomised controlled cross-over trial with questionnaire and interviews. Topical opioids versus placebo.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
PRN (pro re nata - as needed) and regular analgesia requirement over preceding 24 h. Daily pain score and questionnaire regarding side-effects.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2003
Overall trial end date
31/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
20 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).
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
20
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/06/2003
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Dermatology
Coventry
CV2 2DX
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 Hospitals Coventry and Warwickshire 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
Basic results (scientific)
Publication list