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Lidocaine Plaster for Post-Knee Surgery Neuropathic Pain
NCT02763592Phase 2
Key facts
- Status
- Completed
- Start
- May 2016
- Primary completion
- Mar 2017
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- lidocaine
- Conditions
- neuropathic pain
01
Overview
Phase 2, randomised, double-blind trial in neuropathic pain comparing Lidocaine 5% Plaster with Placebo Plaster (2 arms). Primary endpoint: Time to response to treatment at 3 months. Started May 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Lidocaine 5% Plaster
5% lidocaine medicated plaster (5LP)
Placebo Plaster
Placebo plaster
03
Who it enrols
Adult patients (18-80 years) with localized post-operative neuropathic pain (PONP) following knee surgery at least 3 months prior, with DN4 score >= 4 and brush-induced mechanical allodynia (DMA) >= 5/10. Patients must be naive to Versatis treatment and on stable systemic analgesics.
04
Endpoints
Primary
Time to response to treatment
Secondary
Kinetics of evolution over time of pain evaluated by numeric scale with brush-induced Dynamic Mechanical Allodynia
Kinetics of evolution over time of pain evaluated by numeric scale with Mechanical Detection Threshold
Kinetics of evolution over time of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT)
Pain evaluated with numerical rating scale
Pathophysiology of neuropathic characteristics with DN4 questionnaire
Evolution of the size of the allodynic area
Responder rate (30% and 50% reduction) on pain with brush-induced Dynamic Mechanical Allodynia
Responder rate (30% and 50% reduction) on pain with Mechanical Detection Threshold
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