Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-01-11 @ 12:50 AM
Study NCT ID:
NCT03348735
Status:
TERMINATED
Last Update Posted:
2021-04-28
First Post:
2017-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-09-17', 'releaseDate': '2024-05-07'}], 'estimatedResultsFirstSubmitDate': '2024-05-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002211', 'term': 'Capsaicin'}, {'id': 'D057968', 'term': 'Transdermal Patch'}, {'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D053284', 'term': 'Polyunsaturated Alkamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'whyStopped': 'Low inclusion rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2017-11-16', 'studyFirstSubmitQcDate': '2017-11-20', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-related quality of life questionnaire', 'timeFrame': '24 months', '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.'}], 'secondaryOutcomes': [{'measure': 'Pain relief', 'timeFrame': 'from week 0 up to 26 weeks', '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)'}, {'measure': 'Health-related quality of life', 'timeFrame': 'from week 0 up to 26 weeks', 'description': 'AUC for EQ-5D-5L measurements, global perceived effect (GPE), effect on mood (HADS), quality of sleep (NRS and ISI).'}, {'measure': 'Drug tolerance', 'timeFrame': 'from week 0 up to 26 weeks', 'description': 'Percentage of patients without systemic drug related side effects, percentage of patients who discontinue the study drug.'}, {'measure': 'Functional status of the patient', 'timeFrame': 'from week 0 up to 26 weeks', 'description': 'Impact of pain on functioning (Interference - BPI), participation in activities (Utrecht Work Engagement Scale), Work Productivity and Activity Impairment (WPAI).'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuropathic Pain']}, 'referencesModule': {'references': [{'pmid': '37089721', 'type': 'DERIVED', 'citation': 'Hans GH, Almeshal D, Vanlommel L, Roelant E, Verhaegen I, Smits E, Van Boxem K, Fontaine R, Investigators Team TP. Considerations on the Obstacles That Lead to Slow Recruitment in a Pain Management Clinical Trial: Experiences from the Belgian PELICAN (PrEgabalin Lidocaine Capsaicin Neuropathic Pain) Pragmatic Study. Pain Res Manag. 2023 Apr 14;2023:7708982. doi: 10.1155/2023/7708982. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': '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)).', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients eligible for inclusion in this study must fulfil all of the following criteria:\n\n* Subjects should be capable of giving their informed consent with sufficient knowledge of the Dutch, French or German language;\n* Males and females, 18 years and older;\n* Be assessed as suffering from moderate to severe neuropathic pain across the screening process with pain intensity (numeric rating scale - NRS) ≥ 4/10,\n* At the time of screening pain symptoms have to be present for at least one (1) month, with a maximum of 24 months;\n* Sensory disturbances present in the skin area of maximal pain;\n* At the time of screening pain is clearly related to the presence of a localized neuropathic pain syndrome.\n* 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;\n* Women can only be included after negative pregnancy test;\n\nExclusion Criteria:\n\n* Age \\< 18;\n* Pregnant and breastfeeding women;\n* Infection in the painful skin region;\n* 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;\n* Known and/or strong suspicion of allergy to the study medication, known skin disorder (resulting in disruption of the normal skin barrier);\n* 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;\n* Risk of heart failure and/or renal failure.'}, 'identificationModule': {'nctId': 'NCT03348735', 'acronym': 'PELICAN', 'briefTitle': 'Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'R017007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine patch 5%', 'description': 'Lidocaine 5% medicated plasters will be applied daily, during 12 consecutive hours.', 'interventionNames': ['Drug: Lidocaine patch 5%']}, {'type': 'EXPERIMENTAL', 'label': 'Capsaicin 8% patch', '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).', 'interventionNames': ['Drug: Capsaicin 8% Patch']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pregabaline', '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.', 'interventionNames': ['Drug: Pregabalin']}], 'interventions': [{'name': 'Lidocaine patch 5%', 'type': 'DRUG', 'description': 'Application of Lidocaine 5% patch for 12 hours.', 'armGroupLabels': ['Lidocaine patch 5%']}, {'name': 'Capsaicin 8% Patch', 'type': 'DRUG', 'description': 'Application of Capsaicin 8% patch for', 'armGroupLabels': ['Capsaicin 8% patch']}, {'name': 'Pregabalin', 'type': 'DRUG', 'description': 'Oral treatment with pregabalin (75mg capsules) will be used at optimized doses to best match clinical practice in Europe.', 'armGroupLabels': ['Pregabaline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'University hospital Antwerp', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '2018', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'AZ Monica (campus Antwerpen)', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '2930', 'city': 'Brasschaat', 'country': 'Belgium', 'facility': 'AZ Klina', 'geoPoint': {'lat': 51.2912, 'lon': 4.49182}}, {'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'AZ Sint Jan Brugge', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'UVC Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '6000', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'Grand Hôpital de Charleroi', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '3600', 'city': 'Genk', 'country': 'Belgium', 'facility': 'Ziekenhuis Oost-Limburg (ZOL', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent (UZG)', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '1090', 'city': 'Jette', 'country': 'Belgium', 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Leuven (UZL)', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Hopital Universitaire Sart Tilman de Liège (ULg) (CHU)', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '8800', 'city': 'Roeselare', 'country': 'Belgium', 'facility': 'AZ Delta', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'zip': '2300', 'city': 'Turnhout', 'country': 'Belgium', 'facility': 'AZ Turnhout', 'geoPoint': {'lat': 51.32254, 'lon': 4.94471}}], 'overallOfficials': [{'name': 'Guy Hans, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Davina Wildemeersch', 'investigatorAffiliation': 'University Hospital, Antwerp'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-05-07', 'type': 'RELEASE'}, {'date': '2024-09-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Davina Wildemeersch, Principle investigator, University Hospital, Antwerp'}}}}