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
|Condition or disease||Intervention/treatment||Phase|
|Neuropathic Pain||Drug: Lidocaine patch 5% Drug: Capsaicin 8% Patch Drug: Pregabalin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|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.|
|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|
|Actual Primary Completion Date :||April 19, 2021|
|Actual Study Completion Date :||April 19, 2021|
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.
Oral treatment with pregabalin (75mg capsules) will be used at optimized doses to best match clinical practice in Europe.
- 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.
- 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).
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
|University hospital Antwerp|
|Edegem, Antwerp, Belgium, 2650|
|AZ Monica (campus Antwerpen)|
|Antwerp, Belgium, 2018|
|Brasschaat, Belgium, 2930|
|AZ Sint Jan Brugge|
|Brugge, Belgium, 8000|
|Brussels, Belgium, 1020|
|Grand Hôpital de Charleroi|
|Charleroi, Belgium, 6000|
|Ziekenhuis Oost-Limburg (ZOL|
|Genk, Belgium, 3600|
|Universitair Ziekenhuis Gent (UZG)|
|Gent, Belgium, 9000|
|Jette, Belgium, 1090|
|Universitair Ziekenhuis Leuven (UZL)|
|Leuven, Belgium, 3000|
|Hopital Universitaire Sart Tilman de Liège (ULg) (CHU)|
|Liège, Belgium, 4000|
|Roeselare, Belgium, 8800|
|Turnhout, Belgium, 2300|
|Principal Investigator:||Guy Hans, MD, PhD||University Hospital, Antwerp|