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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 17 October 2016
Main ID:  ISRCTN76288165
Date of registration: 12/09/2003
Prospective Registration: No
Primary sponsor: Department of Health (UK)
Public title: Randomised placebo controlled cross-over trial of topical opioids in the management of analgesia in leg ulcers
Scientific title: Randomised placebo controlled cross-over trial of topical opioids in the management of analgesia in leg ulcers
Date of first enrolment: 01/06/2003
Target sample size: 20
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN76288165
Study type:  Interventional
Study design:  Randomised controlled trial (Not Specified)  
Phase:  Not Specified
Countries of recruitment
United Kingdom
Contacts
Name: Joanne    Deacon
Address:  Department of Dermatology UHCW NHS Trust Clifford Bridge Road CV2 2DX Coventry United Kingdom
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
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Affiliation: 
Key inclusion & exclusion criteria
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).
Exclusion criteria: Does not match inclusion criteria

Age minimum:
Age maximum:
Gender: Not Specified
Health Condition(s) or Problem(s) studied
Signs and Symptoms: Pain
Skin and Connective Tissue Diseases
Other disorders of skin and subcutaneous tissue, not elsewhere classified
Intervention(s)
Prospective randomised controlled cross-over trial with questionnaire and interviews. Topical opioids versus placebo.
Primary Outcome(s)
PRN (pro re nata - as needed) and regular analgesia requirement over preceding 24 h. Daily pain score and questionnaire regarding side-effects.
Secondary Outcome(s)
Not provided at time of registration
Secondary ID(s)
N0295122854
Source(s) of Monetary Support
University Hospitals Coventry and Warwickshire NHS Trust (UK)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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