Dettagli per singolo studio

DEC-NET Serial number GB263

Published online	30/06/2004 11.08.00
Last updated	02/08/2005 13.17.30

Other protocol ID number	N0012101637
This trial has been approved by an ethics committee
Current trial status	Open (actively recruiting new participants)
First subject enrolment Target N. of subjects	08/2001 N/A
Major Disease (ICD9 class)	OTHER SPECIFIED CONGENITAL ANOMALIES OF SKIN
Experimental drug
MORPHINE Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	2 to 11 years
Eligibility criteria
Inclusion criteria
Children with epidermolysis bullosa
Exclusion criteria
Informed consent not been given Children refuse to follow protocol
Trial design/methodology
Phase	3
Kind of study	Efficacy
Design	Controlled Randomised Blinded Double blind Cross-over
Purpose of study
To establish the anlgesic efficacy of topical morphine in paediatric patients with epidermolysis bullosa
Primary outcomes
The clinical outcome will be a reduction in the pain experiences by the patients as well as an overall improvement in quality of life


Summary of study design, objectives, and ongoing research findings
Randomised controlled trial; Random allocation to (A) Treatment for epidermolysis bullosa (B) Placebo. Aim: To establish the anlgesic efficacy of topical morphine in paediatric patients with epidermolysis bullosa The clinical outcome will be a reduction in the pain experiences by the patients as well as an overall improvement in quality of life