Localized neuropathic pain: a study to compare topical treatment versus systemic treatment - PELICAN (KCE-17007)

Summary (French or Dutch)

 

Neuropathic pain (NP) caused by lesions within the somatosensory nervous system, has a considerable impact on patients’ quality of life, and is associated with high economic burden. When NP affects a clearly demarcated area of the body it can be described as localized neuropathic pain (LNP). LNP affects over 431,000 individuals in Belgium.

In routine clinical practice, LNP patients receive oral pharmacological drugs as first-line therapy. However, hardly one-third of these patients achieve satisfying analgesia. When increasing drug dosage fails to reduce pain, treatment is adapted to a drug from a different group. During this exhausting phase of trial and error, outcome can be biased by decreasing patient compliance. Topical treatment options may be an excellent alternative. Two topical agents are currently licensed, lidocaine 5% medicated plaster and capsaicin 8% patch.

Considering the limited scientific evidence, there is a need for studies to enable direct comparisons with current first-line oral therapies. Tailored protocols, approaching real-life settings, with a congruous number of patients, proper randomization, long duration and health-related quality of life indicators, are of importance for the further conceptualization of topical treatment of LNP.

The proposed pragmatic trial is designed to evaluate effectiveness of topical intervention, compared to current oral standard of care. The results can be applied in routine Belgian practice, providing LNP patients first-line topical treatment strategies.

 

 

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

 

 
Documents
Protocol  
Report

Expected for Q1 2021

Publication

Expected for Q2 2021

References

Clinicaltrials.gov: NCT03348735

Webpage: 

Funding scheme

Investigator-led workstream 2017