Clinical trial NCT03348735: Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Neuropathic Pain
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicentre, randomized, open-label comparative trial evaluating topical treatment options (lidocaine 5% or capsaicine 8% patch) versus oral systemic treatment (pregabaline as standard of care) in adult patients suffering from localized neuropathic pain (LNP) syndromes.
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Patients eligible for inclusion in this study must fulfil all of the following criteria:

* Subjects should be capable of giving their informed consent with sufficient knowledge of the Dutch, French or German language;
* Males and females, 18 years and older;
* Be assessed as suffering from moderate to severe neuropathic pain across the screening process with pain intensity (numeric rating scale - NRS) ≥ 4/10,
* At the time of screening pain symptoms have to be present for at least one (1) month, with a maximum of 24 months;
* Sensory disturbances present in the skin area of maximal pain;
* At the time of screening pain is clearly related to the presence of a localized neuropathic pain syndrome.
* Male or female patients of child producing potential\* must agree to use contraception or take measures to avoid pregnancy during the study and until after the final treatment;
* Women can only be included after negative pregnancy test;

Exclusion Criteria:

* Age \< 18;
* Pregnant and breastfeeding women;
* Infection in the painful skin region;
* Poorly healed or non-healed wound or scar in the painful skin region as well as presence of cutaneous abnormalities (non-intact skin barrier) within the painful skin region related to dermatological conditions;
* Known and/or strong suspicion of allergy to the study medication, known skin disorder (resulting in disruption of the normal skin barrier);
* Previous treatment with any of the three medications included in the study protocol for the same painful area within the last 12 months at the time of screening;
* Risk of heart failure and/or renal failure.

Primary outcomes:
measure: Health-related quality of life questionnaire
timeFrame: 24 months
Secondary outcomes:
measure: Pain relief
timeFrame: from week 0 up to 26 weeks
measure: Health-related quality of life
timeFrame: from week 0 up to 26 weeks
measure: Drug tolerance
timeFrame: from week 0 up to 26 weeks
measure: Functional status of the patient
timeFrame: from week 0 up to 26 weeks
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University hospital Antwerp
state: Antwerp
city: Antwerp
country: Belgium
facility: AZ Monica (campus Antwerpen)
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Brugge
country: Belgium
facility: AZ Sint Jan Brugge
city: Brussels
country: Belgium
facility: UVC Brugmann
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg (ZOL
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent (UZG)
city: Jette
country: Belgium
facility: UZ Brussel
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven (UZL)
city: Liège
country: Belgium
facility: Hopital Universitaire Sart Tilman de Liège (ULg) (CHU)
city: Roeselare
country: Belgium
facility: AZ Delta
city: Turnhout
country: Belgium
facility: AZ Turnhout
Study officials:
affiliation: University Hospital, Antwerp
name: Guy Hans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: