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

Not Applicable

Completed

• Conditions: Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases; Skin and Connective Tissue Diseases; Epidermolysis bullosa

• Registration Number: ISRCTN81030001
• Lead Sponsor: niversity College London (UCL) Institute of Child Health (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-18
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

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

Exclusion Criteria

1. Amitriptyline therapy in previous 6 weeks
2. Contra-indication to tricyclic antidepressants

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self assessment of pain using a linear VAS

Secondary Outcome Measures

Name	Time	Method
1. Quantitative assessment of mobility, measured by a physiotherapist<br>2. Reporting of sleep pattern and nocturnal pain