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

ISRCTN	ISRCTN81030001
DOI	https://doi.org/10.1186/ISRCTN81030001
Protocol serial number	3217
Sponsor	University College London (UCL) Institute of Child Health (UK)
Funder	Dystrophic Epidermolysis Bullosa Research Association (DEBRA) (UK)

Submission date: 18/06/2010
Registration date: 18/06/2010
Last edited: 10/08/2016

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 Richard Howard
Scientific

The Somers Clinical Research Facility
Level 1 Frontage Building
Great Ormond Street
London
WC1N 3JH
United Kingdom

Phone	+44 207 829 8865
Email	r.howard@ich.ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Single centre randomised interventional treatment trial
Secondary study design	Randomised controlled trial
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
Study acronym	Amitriptyline in EB Pain
Study objectives	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(s)	MREC approved (ref: 06/Q0508/3)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Amitriptyline
Primary outcome measure(s)	Self assessment of pain using a linear VAS
Key secondary outcome measure(s)	1. Quantitative assessment of mobility, measured by a physiotherapist 2. Reporting of sleep pattern and nocturnal pain
Completion date	12/02/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	18 Years
Sex	Not Specified
Target sample size at registration	40
Key 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
Key exclusion criteria	1. Amitriptyline therapy in previous 6 weeks 2. Contra-indication to tricyclic antidepressants
Date of first enrolment	26/09/2006
Date of final enrolment	12/02/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

The Somers Clinical Research Facility

London
WC1N 3JH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

10/08/21016: No publications found in PubMed, verifying study status with principal investigator.