KCE-17007: Vergleichende Studie zwischen topischer und systemischer Behandlung von lokalisierten neuropathischen Schmerzen - PELICAN-Studie

Zusammenfassung (Niederländisch oder Französisch oder Englisch)

 

Trial Description
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)

Status

Open to recruitment

 

Trial team

Sponsor

Universitaire Ziekenhuizen Antwerpen

Chief Investigator

Prof Dr Guy Hans

Medisch Coördinator Multidisciplinair Pijncentrum

Universitair Ziekenhuis Antwerpen (UZA)

Wilrijkstraat 10

2650 Edegem.

guy.hans@uza.be

 

 
Dokumente
Pelican Study info
Protocol  
Report

Expected for Q1 2021

Publication

Expected for Q2 2021

REFERENZEN

Clinicaltrials.gov: NCT03348735

Webpage: www.uza.be/pelican

FINANZIERUNGSSCHEMA

Investigator-led workstream 2017