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Lidocaine 5% Medicated Plaster for the Topical Treatment of Localized Chronic Postoperative Neuropathic Pain.
The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster.
Details
| Lead sponsor | Grünenthal GmbH |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 74 |
| Start date | 2010-08 |
| Completion | 2012-11 |
Conditions
- Pain
- Chronic Pain
- Neuropathic Pain
- Postoperative Pain
Interventions
- Lidocaine 5% medicated plaster
- Placebo topical plaster
Primary outcomes
- Analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic postoperative neuropathic pain — daily assessments over 4 weeks
Participants will be selected based on their medical history and clinical examination. A questionnaire called DN4, which stands for 'douleur neuropathique 4' (i.e., '4 questions neuropathic pain will be used to identify subjects with neuropathic pain.) Pain will be assessed on and 11-point numerical rating scale (0 = no pain, 10 = worst pain imaginable). Efficacy of the treatment (i.e., reduction of neuropathic pain) will be evaluated with the 11-point numeric rating scale (NRS).
Countries
France