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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN81030001
Enrollment
40
Registered
2010-06-18
Start date
2006-09-26
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Medicines for Children Research Network

Interventions

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 quest

Sponsors

University College London (UCL) Institute of Child Health (UK)
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Self assessment of pain using a linear VAS—

Secondary

MeasureTime frame
1. Quantitative assessment of mobility, measured by a physiotherapist 2. Reporting of sleep pattern and nocturnal pain—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026