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
Secondary identifying numbers	3217

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

Study design	Single centre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Amitriptyline
Primary outcome measure	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 study start date	26/09/2006
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 number of participants	Planned sample size: 40; UK sample size: 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

England
United Kingdom

Study participating centre

The Somers Clinical Research Facility

London
WC1N 3JH
United Kingdom

Sponsor information

University College London (UCL) Institute of Child Health (UK)
University/education

30 Guilford Street
London
WC1N 1EH
England
United Kingdom

Website	http://www.ich.ucl.ac.uk/
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Research organisation

Dystrophic Epidermolysis Bullosa Research Association (DEBRA) (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

Editorial Notes

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