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

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ClinicalTrials.gov Identifier: NCT03348735
Recruitment Status : Terminated (Low inclusion rate)
First Posted : November 21, 2017
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Davina Wildemeersch, University Hospital, Antwerp

Tracking Information
First Submitted Date  ICMJE November 16, 2017
First Posted Date  ICMJE November 21, 2017
Last Update Posted Date April 28, 2021
Actual Study Start Date  ICMJE December 3, 2018
Actual Primary Completion Date April 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
Health-related quality of life questionnaire [ Time Frame: 24 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2017)
Health-related quality of life [ Time Frame: From first questionnaire fill-out (week 0) and after week 16. ]
Change in EQ-5D-5L (Health-related quality of life) between baseline and week 16 (4 months of treatment).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2018)
  • 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)
  • 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).
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2017)
  • Pain intensity [ Time Frame: Weekly online assessment from week 0 up to 26 weeks ]
    Reduction in pain intensity evaluated via online 11-level numeric rating scale questionnaire.
  • Neuropathic Pain Symptom Inventory [ Time Frame: 1 week before first treatment ]
    Neuropathic Pain Symptom Inventory (NPSI), evaluated at screening consultation (at least 7 days before first treatment day), the first treatment day (Day 0)
  • Discontinuation of the study drug [ Time Frame: Overall study time up to 26 weeks ]
    Discontinuation of the study drug defined as stopping the initial treatment
  • Patient global impression of change (PGIC) [ Time Frame: Assessed on a monthly basis from day 0 (first treatment) up to week 26 ]
    Questionnaire filled-out by the patient
  • Systemic drug related side effects [ Time Frame: Screening starts at the first treatment day (Day 0), and a weekly online assessment up to 26 weeks ]
    Systemic drug related side effects defined as dizziness, fatigue, vertigo, somnolence, headache, or blurred vision
  • Hospital Anxiety and Depression Scale [ Time Frame: Assessed on a monthly basis from day 0 (first treatment) up to week 26 ]
    Evaluation of anxiety and depression characteristics by the Hospital Anxiety and Depression Scale (HADs) via online questionnaire
  • Activity participation [ Time Frame: Starts at the first treatment day (Day 0), and a weekly online assessment up to 26 weeks ]
    Participation in activities via 'Utrecht activities list'
  • Pain interference [ Time Frame: Assessed on a monthly basis day 0, week 4, 8, 12, 16, 22 and 26 weeks ]
    Impact of pain on functioning (interference - BPI)
  • Quality of sleep [ Time Frame: Starts at the first treatment day (Day 0), and a weekly online assessment up to 26 ]
    Quality of sleep assessed by an 11-level numeric rating scale
  • Daily activity [ Time Frame: Assessed on a monthly basis day 0, week 4, 8, 12, 16, 22 and 26 weeks ]
    Work Productivity and Activity Impairment (WPAI:Neuropathic Pain, v2.2, Belgium)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Neuropathic Pain
Intervention  ICMJE
  • Drug: Lidocaine patch 5%
    Application of Lidocaine 5% patch for 12 hours.
  • Drug: Capsaicin 8% Patch
    Application of Capsaicin 8% patch for
  • Drug: Pregabalin
    Oral treatment with pregabalin (75mg capsules) will be used at optimized doses to best match clinical practice in Europe.
Study Arms  ICMJE
  • Experimental: Lidocaine patch 5%
    Lidocaine 5% medicated plasters will be applied daily, during 12 consecutive hours.
    Intervention: Drug: Lidocaine patch 5%
  • 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).
    Intervention: Drug: Capsaicin 8% Patch
  • 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.
    Intervention: Drug: Pregabalin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 7, 2020)
33
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2017)
648
Actual Study Completion Date  ICMJE April 19, 2021
Actual Primary Completion Date April 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03348735
Other Study ID Numbers  ICMJE R017007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Davina Wildemeersch, University Hospital, Antwerp
Study Sponsor  ICMJE University Hospital, Antwerp
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guy Hans, MD, PhD University Hospital, Antwerp
PRS Account University Hospital, Antwerp
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP