Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment

NCT ID: NCT03348735

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-03
• Study Completion Date: 2021-04-19

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).

Conditions

Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lidocaine patch 5%

Lidocaine 5% medicated plasters will be applied daily, during 12 consecutive hours.

Group Type: EXPERIMENTAL

Lidocaine patch 5%

Intervention Type: DRUG

Application of Lidocaine 5% patch for 12 hours.

Capsaicin 8% patch

Capsaicin 8% patches need to applied in a hospital setting during 1 hour. Re-application of these capsaicin patches will be performed upon re-occurrence of painful symptoms (mostly after 12 weeks - so not after a fixed time interval). Application of capsaicin patches will be carried out in a hospital setting (+/- 3 hours procedure).

Group Type: EXPERIMENTAL

Capsaicin 8% Patch

Intervention Type: DRUG

Application of Capsaicin 8% patch for

Pregabaline

Oral treatment with pregabalin (75mg capsules) will be used at optimized doses to best match clinical practice in Europe. In European clinical practice, up-titration of the dose is often carried out over a longer time-period. This study thus includes up-titration schedule for pregabalin over a period of 4 weeks. If patients develop side-effects during the intake/uptitration of pregabalin this treatment can be stopped and switched to gabapentin (300mg capsules). Gabapentin will always be the back-up treatment for failed systematic treatment with pregabalin. Dose of gabapentin will be uptitrated to maximum 1200mg per day.

Group Type: ACTIVE_COMPARATOR

Pregabalin

Intervention Type: DRUG

Oral treatment with pregabalin (75mg capsules) will be used at optimized doses to best match clinical practice in Europe.

Interventions

Lidocaine patch 5%

Application of Lidocaine 5% patch for 12 hours.

Intervention Type: DRUG

Capsaicin 8% Patch

Application of Capsaicin 8% patch for

Intervention Type: DRUG

Pregabalin

Oral treatment with pregabalin (75mg capsules) will be used at optimized doses to best match clinical practice in Europe.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Davina Wildemeersch

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guy Hans, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

University hospital Antwerp

Edegem, Antwerp, Belgium

AZ Monica (campus Antwerpen)

Antwerp, , Belgium

AZ Klina

Brasschaat, , Belgium

AZ Sint Jan Brugge

Bruges, , Belgium

UVC Brugmann

Brussels, , Belgium

Grand Hôpital de Charleroi

Charleroi, , Belgium

Ziekenhuis Oost-Limburg (ZOL

Genk, , Belgium

Universitair Ziekenhuis Gent (UZG)

Ghent, , 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, , Belgium

Countries

Belgium

References

Hans GH, Almeshal D, Vanlommel L, Roelant E, Verhaegen I, Smits E, Van Boxem K, Fontaine R, Investigators Team TP. Considerations on the Obstacles That Lead to Slow Recruitment in a Pain Management Clinical Trial: Experiences from the Belgian PELICAN (PrEgabalin Lidocaine Capsaicin Neuropathic Pain) Pragmatic Study. Pain Res Manag. 2023 Apr 14;2023:7708982. doi: 10.1155/2023/7708982. eCollection 2023.

Reference Type: DERIVED

PMID: 37089721 (View on PubMed)

Other Identifiers

R017007

Identifier Type: -

Identifier Source: org_study_id