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

Primary Purpose

Neuropathic Pain

Status
Terminated
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Lidocaine patch 5%
Capsaicin 8% Patch
Pregabalin
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University hospital Antwerp
  • AZ Monica (campus Antwerpen)
  • AZ Klina
  • AZ Sint Jan Brugge
  • UVC Brugmann
  • Grand Hôpital de Charleroi
  • Ziekenhuis Oost-Limburg (ZOL
  • Universitair Ziekenhuis Gent (UZG)
  • UZ Brussel
  • Universitair Ziekenhuis Leuven (UZL)
  • Hopital Universitaire Sart Tilman de Liège (ULg) (CHU)
  • AZ Delta
  • AZ Turnhout

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Lidocaine patch 5%

Capsaicin 8% patch

Pregabaline

Arm Description

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

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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).
Drug tolerance
Percentage of patients without systemic drug related side effects, percentage of patients who discontinue the study drug.
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).

Full Information

First Posted
November 16, 2017
Last Updated
April 27, 2021
Sponsor
University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT03348735
Brief Title
Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Low inclusion rate
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
April 19, 2021 (Actual)
Study Completion Date
April 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp

4. Oversight

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

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine patch 5%
Arm Type
Experimental
Arm Description
Lidocaine 5% medicated plasters will be applied daily, during 12 consecutive hours.
Arm Title
Capsaicin 8% patch
Arm Type
Experimental
Arm Description
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).
Arm Title
Pregabaline
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine patch 5%
Intervention Description
Application of Lidocaine 5% patch for 12 hours.
Intervention Type
Drug
Intervention Name(s)
Capsaicin 8% Patch
Intervention Description
Application of Capsaicin 8% patch for
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Oral treatment with pregabalin (75mg capsules) will be used at optimized doses to best match clinical practice in Europe.
Primary Outcome Measure Information:
Title
Health-related quality of life questionnaire
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Pain relief
Description
Reduction in pain intensity (PI-NRS), time to worsening of the pain (PI-NRS and NPSI) and use of rescue medication (MSQ III-R)
Time Frame
from week 0 up to 26 weeks
Title
Health-related quality of life
Description
AUC for EQ-5D-5L measurements, global perceived effect (GPE), effect on mood (HADS), quality of sleep (NRS and ISI).
Time Frame
from week 0 up to 26 weeks
Title
Drug tolerance
Description
Percentage of patients without systemic drug related side effects, percentage of patients who discontinue the study drug.
Time Frame
from week 0 up to 26 weeks
Title
Functional status of the patient
Description
Impact of pain on functioning (Interference - BPI), participation in activities (Utrecht Work Engagement Scale), Work Productivity and Activity Impairment (WPAI).
Time Frame
from week 0 up to 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Hans, MD, PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
AZ Monica (campus Antwerpen)
City
Antwerp
ZIP/Postal Code
2018
Country
Belgium
Facility Name
AZ Klina
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Facility Name
AZ Sint Jan Brugge
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
UVC Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Grand Hôpital de Charleroi
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Ziekenhuis Oost-Limburg (ZOL
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent (UZG)
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Brussel
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven (UZL)
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Hopital Universitaire Sart Tilman de Liège (ULg) (CHU)
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
AZ Turnhout
City
Turnhout
ZIP/Postal Code
2300
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment

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