Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment

NCT03348735 | Terminated Phase 4

• 1 other identifier: R017007
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 13

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)).

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain relief

  from week 0 up to 26 weeks

• Health-related quality of life

  from week 0 up to 26 weeks

• Drug tolerance

  from week 0 up to 26 weeks

• Functional status of the patient

  from week 0 up to 26 weeks

Study Arms (3)

Lidocaine patch 5%

EXPERIMENTAL

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

Drug: Lidocaine patch 5%

Capsaicin 8% patch

EXPERIMENTAL

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).

Drug: Capsaicin 8% Patch

Pregabaline

ACTIVE COMPARATOR

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.

Drug: Pregabalin

Interventions

Lidocaine patch 5% DRUG

Application of Lidocaine 5% patch for 12 hours.

Lidocaine patch 5%

Capsaicin 8% Patch DRUG

Application of Capsaicin 8% patch for

Capsaicin 8% patch

Pregabalin DRUG

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

Pregabaline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (13)

University hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

AZ Monica (campus Antwerpen)

Antwerp, 2018, Belgium

Location

AZ Klina

Brasschaat, 2930, Belgium

Location

AZ Sint Jan Brugge

Bruges, 8000, Belgium

Location

UVC Brugmann

Brussels, 1020, Belgium

Location

Grand Hôpital de Charleroi

Charleroi, 6000, Belgium

Location

Ziekenhuis Oost-Limburg (ZOL

Genk, 3600, Belgium

Location

Universitair Ziekenhuis Gent (UZG)

Ghent, 9000, Belgium

Location

UZ Brussel

Jette, 1090, Belgium

Location

Universitair Ziekenhuis Leuven (UZL)

Leuven, 3000, Belgium

Location

Hopital Universitaire Sart Tilman de Liège (ULg) (CHU)

Liège, 4000, Belgium

Location

AZ Delta

Roeselare, 8800, Belgium

Location

AZ Turnhout

Turnhout, 2300, Belgium

Location

Related Publications (1)

• 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.

  PMID: 37089721 DERIVED

MeSH Terms

Conditions

Neuralgia

Interventions

Capsaicin; Transdermal Patch; Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Equipment and Supplies; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Guy Hans, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Stratified randomization by site and Neuropathic Pain Symptom Inventory (NPSI) will be applied, and coordinated centrally which randomizes eligible patients to one of three treatment arms, and assigns patient numbers. Medication will be dispensed by the hospital pharmacies of the individual participating multidisciplinary pain centres, after proper labelling.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 21, 2017
• Study Start: December 3, 2018
• Primary Completion: April 19, 2021
• Study Completion: April 19, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

BE (13)