Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Title |
Safety, efficacy and patient acceptability of topical treatment versus systemic treatment: a randomized, multicenter, comparative pragmatic trial in adult patients suffering from diverse localized neuropathic pain (LNP) syndromes. PELICAN (PrEgabalinLIdocaineCApsaicinNeuropathicpain) - KCE-17007 |
Participants (P) |
Adult patients suffering from localized neuropathic pain (LNP) across a wide variety of etiologies, with a duration between 1 and 12 months (subacute to chronic neuropathic pain conditions). |
Intervention (I) |
Topical treatment 1: lidocaine 5% medicated plaster (Versatis)Topical treatment 2: capsaicin 8% patch (Qutenza) |
Control (C) |
Systemic treatment: pregabalin (Lyrica) |
Outcome (O) |
The primary outcome is the change in quality of life for the patient, measured by EQ-5D-5L from baseline to 6 weeks. |
Trial Design |
Multicenter three arm 1:1:1 randomized, open-label comparative trial. |
Sample Size |
591 |
Trial duration |
27 months |
Budget |
€M2.83 (incl. VAT) |
Sponsor |
Universitaire Ziekenhuizen Antwerpen |
Chief Investigator |
Prof Dr Guy Hans Medisch Coördinator Multidisciplinair Pijncentrum Universitair Ziekenhuis Antwerpen (UZA) Wilrijkstraat 10 2650 Edegem. |
|
Pelican Study info (567.25 KB) "pdf" | |
Protocol | click here |
Report | |
Publication |
Clinicaltrials.gov: NCT03348735
Webpage: www.uza.be/pelican
Investigator-led workstream 2017