Condition category
Skin and Connective Tissue Diseases
Date applied
18/06/2010
Date assigned
18/06/2010
Last edited
10/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ich.ucl.ac.uk/

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

Publication citations

Additional files

Editorial Notes

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