Contact information
Type
Scientific
Primary contact
Dr Richard Howard
ORCID ID
Contact details
The Somers Clinical Research Facility
Level 1 Frontage Building
Great Ormond Street
London
WC1N 3JH
United Kingdom
+44 207 829 8865
r.howard@ich.ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
3217
Study information
Scientific title
Double blind, placebo controlled crossover study of the efficacy and side effects of low dose amitriptyline treatment for chronic pain, disordered sleep and reduced mobility in children with Epidermolysis Bullosa
Acronym
Amitriptyline in EB Pain
Study hypothesis
In this study we propose to investigate the analgesic efficacy of low dose oral amitriptyline in a randomised, double blind, crossover design trial in children 8 - 18 years with Epidermolysis Bullosa (EB), a painful hereditary skin condition.
Ethics approval
MREC approved (ref: 06/Q0508/3)
Study design
Single centre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases
Intervention
Child Activity Limitation Interview (CALI):
In addition to classical pain measurement, using the Visual Analogue Scales (VAS), quality of life will be measured using a simple, recently developed questionnaire tool (the CALI) which defines impairments in patient selected developmentally appropriate activities.
Mobility:
Mobility will be assessed by a physiotherapist, with particular emphasis on quantifiable parameters of walking gait including use of the GAITERITE commercial measurement system.
Side effects:
Side effects will be monitored, cardiovascular effects will be investigated using ECG (electrocardiograph) and echocardiography.
Intervention type
Drug
Phase
Not Applicable
Drug names
Amitriptyline
Primary outcome measures
Self assessment of pain using a linear VAS
Secondary outcome measures
1. Quantitative assessment of mobility, measured by a physiotherapist
2. Reporting of sleep pattern and nocturnal pain
Overall trial start date
26/09/2006
Overall trial end date
12/02/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children age 6 - 18 years
2. EB and pain
3. Not responding to conventional analgesia
4. Undergoing ongoing care at Great Ormond Street Hospital
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
Planned sample size: 40; UK sample size: 40
Participant exclusion criteria
1. Amitriptyline therapy in previous 6 weeks
2. Contra-indication to tricyclic antidepressants
Recruitment start date
26/09/2006
Recruitment end date
12/02/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Somers Clinical Research Facility
London
WC1N 3JH
United Kingdom
Sponsor information
Organisation
University College London (UCL) Institute of Child Health (UK)
Sponsor details
30 Guilford Street
London
WC1N 1EH
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Dystrophic Epidermolysis Bullosa Research Association (DEBRA) (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
Results - basic reporting
Publication summary