Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment (PELICAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03348735
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Davina Wildemeersch, University Hospital, Antwerp

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 12 months (subacute to chronic neuropathic pain (NP)).

Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: Lidocaine patch 5% Drug: Capsaicin 8% Patch Drug: Pregabalin Phase 4

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 591 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: 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
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lidocaine patch 5%
Lidocaine 5% medicated plasters will be applied daily, during 12 consecutive hours.
Drug: Lidocaine patch 5%
Application of Lidocaine 5% patch for 12 hours.

Experimental: 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).
Drug: Capsaicin 8% Patch
Application of Capsaicin 8% patch for

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




Primary Outcome Measures :
  1. Health-related quality of life [ Time Frame: From first questionnaire fill-out (week 0) and after week 6. ]
    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 12 months.


Secondary Outcome Measures :
  1. Pain relief [ Time Frame: from week 0 up to 26 weeks ]
    Reduction in pain intensity (PI-NRS), time to worsening of the pain (PI-NRS and NPSI) and use of rescue medication (MSQ III-R)

  2. Health-related quality of life [ Time Frame: from week 0 up to 26 weeks ]
    AUC for EQ-5D-5L measurements, global perceived effect (GPE), effect on mood (HADS), quality of sleep (NRS and ISI).

  3. Drug tolerance [ Time Frame: from week 0 up to 26 weeks ]
    Percentage of patients without systemic drug related side effects, percentage of patients who discontinue the study drug.

  4. Functional status of the patient [ Time Frame: from week 0 up to 26 weeks ]
    Impact of pain on functioning (Interference - BPI), participation in activities (Utrecht Work Engagement Scale), Work Productivity and Activity Impairment (WPAI).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 or French 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 12 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 within the last 12 months at the time of screening;
  • Previous treatment with any of the study medications included in the study protocol for the same painful area
  • Risk of heart failure and/or renal failure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348735


Contacts
Layout table for location contacts
Contact: Elke Smits, MD, PhD 03 821 40 49 ext 0032 elke.smits@uza.be
Contact: Inge Michielsens 03 821 44 03 ext 0032 inge.michielsens@uza.be

Locations
Layout table for location information
Belgium
University hospital Antwerp Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Davina Wildemeersch, MD    03 821 58 91 ext 0032    davina.wildemeersch@uza.be   
Sub-Investigator: Davina Wildemeersch, MD         
Sub-Investigator: Kristof Deseure, PhD         
Sub-Investigator: Marcel Vercauteren, MD, PhD         
Principal Investigator: Guy Hans, MD, PhD         
Sub-Investigator: Marc Ceuppens         
Sub-Investigator: Hilde De Belder         
Sub-Investigator: Nadia Meysman         
Sub-Investigator: Ella Roelant         
AZ Monica (campus Antwerpen) Not yet recruiting
Antwerp, Belgium, 2018
Contact: Ewa Brzezinska       ewa.brzezinska@azmonica.be;   
Principal Investigator: Ewa Brzezinska         
AZ Klina Recruiting
Brasschaat, Belgium, 2930
Contact: Mirella Dingens       mirella.dingens@azklina.be   
Principal Investigator: Mirella Dingenen         
Hopital Universitaire Saint Luc (UCL) Not yet recruiting
Brussel, Belgium, 1200
Contact: Anne Berquin       anne.berquin@uclouvain.be   
Principal Investigator: Anne Berquin         
Ziekenhuis Oost-Limburg (ZOL Recruiting
Genk, Belgium, 3600
Contact: Koen Van Boxem       koen.vanboxem@zol.be   
Principal Investigator: Keon Van Boxem         
Universitair Ziekenhuis Gent (UZG) Not yet recruiting
Gent, Belgium, 9000
Contact: Erwin Crombez       erwin.crombez@ugent.be   
Principal Investigator: Erwin Crombez         
Universitair Ziekenhuis Leuven (UZL) Not yet recruiting
Leuven, Belgium, 3000
Contact: Bart Morlion       bart.morlion@uzleuven.be   
Principal Investigator: Bart Morlion         
Hopital Universitaire Sart Tilman de Liège (ULg) (CHU) Recruiting
Liège, Belgium, 4000
Contact: Robert Fontaine       robert.fontaine@chu.ulg.ac.be   
Principal Investigator: Robert Fontaine         
AZ Turnhout Not yet recruiting
Turnhout, Belgium, 2300
Contact: Frans Van De Perck         
Principal Investigator: Frans Van De Perck         
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
Layout table for investigator information
Principal Investigator: Guy Hans, MD, PhD University Hospital, Antwerp

Layout table for additonal information
Responsible Party: Davina Wildemeersch, Principle investigator, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03348735     History of Changes
Other Study ID Numbers: R017007
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuromuscular Diseases
Lidocaine
Neuralgia
Peripheral Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Capsaicin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anticonvulsants
Calcium Channel Blockers
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Antipruritics
Dermatologic Agents