NCT03348735

Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment

Safety, Efficacy and Patient Acceptability of Topical Treatment Versus Systemic Treatment: a Randomized, Multicentre, Comparative Pragmatic Trial in Adult Patients Suffering From Diverse Localized Neuropathic Pain (LNP) Syndromes

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of topical treatment with lidocaine 5% patch (daily administration) or capsaicin 8% patch (periodic administration - upon reoccurrence of pain symptoms) in adult patients suffering from localized neuropathic pain (LNP) across a wide variety of etiologies, with a duration between 1 and 24 months (subacute to chronic neuropathic pain (NP)).

Detailed description

A multicentre, randomized, open-label comparative trial evaluating topical treatment options versus oral systemic treatment in adult patients suffering from localized neuropathic pain (LNP) syndromes. A wide variety of peripheral neuropathic pain syndromes will be included such as post-herpetic neuralgia (PHN), post-surgical NP/post-traumatic NP/scar pain, post-amputation NP, post-radiation therapy NP, complex regional pain syndrome (CRPS) type 1. In contrast to most (or even all) commercial clinical studies we will not limit the inclusion to one or two distinct neuropathic pain syndromes such as post-herpetic neuralgia (inclusion based on etiology of the neuropathic syndrome). In this pragmatic trial we will however include all patients suffering from a clinical neuropathic syndrome with distinct clinical features such as hyperalgesia/allodynia, presence of spontaneous positive sensory phenomena and lasting for more than 3 months without making any exclusion based on etiology. Initial pain intensity indicates the presence of either moderate or severe pain in these adult patients (NRS 4/10).

Conditions

• Neuropathic Pain

Interventions

Type	Name	Description
DRUG	Lidocaine patch 5%	Application of Lidocaine 5% patch for 12 hours.
DRUG	Capsaicin 8% Patch	Application of Capsaicin 8% patch for
DRUG	Pregabalin	Oral treatment with pregabalin (75mg capsules) will be used at optimized doses to best match clinical practice in Europe.

Timeline

• Start date: 2018-12-03
• Primary completion: 2021-04-19
• Completion: 2021-04-19
• First posted: 2017-11-21
• Last updated: 2021-04-28

Locations

13 sites across 1 country: Belgium