Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment

Neuropathic Pain Clinical Trial

— PELICAN  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03348735
• Other study ID #: R017007
• Status: Terminated
• Phase: Phase 4
• Start date: December 3, 2018
• Est. completion date: April 19, 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: April 19, 2021
• Est. primary completion date: April 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

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

Locations

Country	Name	City	State
Belgium	AZ Monica (campus Antwerpen)	Antwerp
Belgium	AZ Klina	Brasschaat
Belgium	AZ Sint Jan Brugge	Brugge
Belgium	UVC Brugmann	Brussels
Belgium	Grand Hôpital de Charleroi	Charleroi
Belgium	University hospital Antwerp	Edegem	Antwerp
Belgium	Ziekenhuis Oost-Limburg (ZOL	Genk
Belgium	Universitair Ziekenhuis Gent (UZG)	Gent
Belgium	UZ Brussel	Jette
Belgium	Universitair Ziekenhuis Leuven (UZL)	Leuven
Belgium	Hopital Universitaire Sart Tilman de Liège (ULg) (CHU)	Liège
Belgium	AZ Delta	Roeselare
Belgium	AZ Turnhout	Turnhout

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life questionnaire	To determine if topical treatment significantly improves health-related quality of life compared to systemic treatment in adult patients suffering from localized neuropathic pain across a wide variety of etiologies (LNP), with a duration between 1 and 24 months.	24 months
Secondary	Pain relief	Reduction in pain intensity (PI-NRS), time to worsening of the pain (PI-NRS and NPSI) and use of rescue medication (MSQ III-R)	from week 0 up to 26 weeks
Secondary	Health-related quality of life	AUC for EQ-5D-5L measurements, global perceived effect (GPE), effect on mood (HADS), quality of sleep (NRS and ISI).	from week 0 up to 26 weeks
Secondary	Drug tolerance	Percentage of patients without systemic drug related side effects, percentage of patients who discontinue the study drug.	from week 0 up to 26 weeks
Secondary	Functional status of the patient	Impact of pain on functioning (Interference - BPI), participation in activities (Utrecht Work Engagement Scale), Work Productivity and Activity Impairment (WPAI).	from week 0 up to 26 weeks