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
|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)|
|Estimated Enrollment :||591 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|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||November 1, 2020|
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 [ 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.
- 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
|Contact: Elke Smits, MD, PhD||03 821 40 49 ext firstname.lastname@example.org|
|Contact: Inge Michielsens||03 821 44 03 ext email@example.com|
|University hospital Antwerp||Recruiting|
|Edegem, Antwerp, Belgium, 2650|
|Contact: Davina Wildemeersch, MD 03 821 58 91 ext 0032 firstname.lastname@example.org|
|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 email@example.com;|
|Principal Investigator: Ewa Brzezinska|
|Brasschaat, Belgium, 2930|
|Contact: Mirella Dingens firstname.lastname@example.org|
|Principal Investigator: Mirella Dingenen|
|Hopital Universitaire Saint Luc (UCL)||Not yet recruiting|
|Brussel, Belgium, 1200|
|Contact: Anne Berquin email@example.com|
|Principal Investigator: Anne Berquin|
|Ziekenhuis Oost-Limburg (ZOL||Recruiting|
|Genk, Belgium, 3600|
|Contact: Koen Van Boxem firstname.lastname@example.org|
|Principal Investigator: Keon Van Boxem|
|Universitair Ziekenhuis Gent (UZG)||Not yet recruiting|
|Gent, Belgium, 9000|
|Contact: Erwin Crombez email@example.com|
|Principal Investigator: Erwin Crombez|
|Universitair Ziekenhuis Leuven (UZL)||Not yet recruiting|
|Leuven, Belgium, 3000|
|Contact: Bart Morlion firstname.lastname@example.org|
|Principal Investigator: Bart Morlion|
|Hopital Universitaire Sart Tilman de Liège (ULg) (CHU)||Recruiting|
|Liège, Belgium, 4000|
|Contact: Robert Fontaine email@example.com|
|Principal Investigator: Robert Fontaine|
|AZ Turnhout||Not yet recruiting|
|Turnhout, Belgium, 2300|
|Contact: Frans Van De Perck|
|Principal Investigator: Frans Van De Perck|
|Principal Investigator:||Guy Hans, MD, PhD||University Hospital, Antwerp|