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
Scientific
Department of Dermatology
UHCW NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised placebo controlled cross-over trial of topical opioids in the management of analgesia in leg ulcers |
| Study objectives | Does 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) studied | Signs and Symptoms: Pain |
| Intervention | Prospective randomised controlled cross-over trial with questionnaire and interviews. Topical opioids versus placebo. |
| Intervention type | Other |
| 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 study start date | 01/06/2003 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 20 |
| Key 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). |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/06/2003 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Dermatology
Coventry
CV2 2DX
United Kingdom
CV2 2DX
United Kingdom
Sponsor information
Department of Health (UK)
Government
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
