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Versatis in chronic neuropathic pain after peripheral nerve injury
NCT01112748Phase 4
Key facts
- Status
- Completed
- Start
- Apr 2010
- Primary completion
- May 2011
- Countries
- 1
- Sponsor
- Danish Pain Research Center
- Modality
- Small Molecules
- Conditions
- neuropathic pain
01
Overview
Phase 4, open-label, single-arm trial of lidocaine 10% oropharyngeal spray in neuropathic pain, sponsored by Danish Pain Research Center. Primary endpoint: Change in pain intensity of spontaneous pain at 12 weeks. Started Apr 2010; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Lidocaine Patch
Topical lidocaine patch 5%
03
Who it enrols
Adult patients with chronic neuropathic pain after peripheral nerve injury (pain intensity >= 4/10). Excludes pregnancy, alcohol abuse, psychiatric disorders, skin diseases in application area, and recent use of Na+ channel blockers or capsaicin.
04
Endpoints
Primary
Change in pain intensity of spontaneous pain
Secondary
Pain relief for spontaneous and evoked pain
Effect on ongoing pain, brush-evoked allodynia, cold and warm allodynia, and pinprick hyperalgesia
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