Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT01416116
Status:
COMPLETED
Last Update Posted:
2018-04-23
First Post:
2011-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059348', 'term': 'Peripheral Nerve Injuries'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002211', 'term': 'Capsaicin'}, {'id': 'D057968', 'term': 'Transdermal Patch'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D014147', 'term': 'Tramadol'}], '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': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2012-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-19', 'studyFirstSubmitDate': '2011-08-11', 'studyFirstSubmitQcDate': '2011-08-11', 'lastUpdatePostDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of subjects who tolerate QUTENZA treatment', 'timeFrame': '60 minute application period', 'description': 'A QUTENZA tolerant subject is defined as a subject receiving at least 90% of the intended patch duration.'}], 'secondaryOutcomes': [{'measure': 'Duration of patch application', 'timeFrame': '60 minutes'}, {'measure': 'Change in pain scores from baseline to subsequent timepoints on the day of patch application', 'timeFrame': '5, 25, 55, 85, 115 minutes on day of application and once a day on days 1, 2, 3'}, {'measure': 'Proportion of subjects using pain medications and dose of pain medication(s) administered', 'timeFrame': 'day 1-5'}, {'measure': 'Subject rated tolerability score', 'timeFrame': 'Baseline to end of study visit, day 7'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tramadol', 'QUTENZA', 'Pre-treatment', 'Tolerability'], 'conditions': ['or Peripheral Nerve Injury (PNI)', 'Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.astellasclinicalstudyresults.com/study.aspx?ID=82', 'label': 'Link to results on Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'The Summary of product characteristics (SmPC) for QUTENZA advises that topical anaesthetic is applied prior to the application of QUTENZA. This is a multi-center, randomized, assessor-blinded study which will investigate the use of an oral analgesic as an alternative form of pre-treatment for QUTENZA.', 'detailedDescription': 'All patients will be treated with QUTENZA for 60 minutes. Patients will be randomized to one of two arms- application of topical anaesthetic (lidocaine cream) or an oral analgesic (tramadol oral tables) prior to application of QUTENZA. Patients will be followed up for 7 days to monitor pain scores and tolerability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of postherpetic neuralgia or neuropathic pain due to peripheral nerve injury\n* Daily pain score ≥ 4 for average pain both at the Screening Visit and at the Treatment Visit\n* Intact, non-irritated, dry skin over the painful area(s) to be treated\n\nExclusion Criteria:\n\n* Significant ongoing or recurrent pain other than due to PHN or peripheral nerve injury\n* Past or current history of Type I or Type II diabetes mellitus\n* Active malignancy or treatment for malignancy within a year prior to the Treatment Visit'}, 'identificationModule': {'nctId': 'NCT01416116', 'acronym': 'LIFT', 'briefTitle': 'Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Tolerability of QUTENZATM When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study', 'orgStudyIdInfo': {'id': 'QTZ-EC-0002'}, 'secondaryIdInfos': [{'id': '2010-023258-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tramadol', 'description': 'Tramadol prior to QUTENZA', 'interventionNames': ['Drug: QUTENZA', 'Drug: Tramadol']}, {'type': 'EXPERIMENTAL', 'label': 'Lidocaine', 'description': 'Lidocaine prior to QUTENZA', 'interventionNames': ['Drug: QUTENZA', 'Drug: Lidocaine']}], 'interventions': [{'name': 'QUTENZA', 'type': 'DRUG', 'otherNames': ['capsaicin 8% patch'], 'description': 'topical', 'armGroupLabels': ['Lidocaine', 'Tramadol']}, {'name': 'Lidocaine', 'type': 'DRUG', 'description': 'topical', 'armGroupLabels': ['Lidocaine']}, {'name': 'Tramadol', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['Tramadol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Site 102', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Genk', 'country': 'Belgium', 'facility': 'Site 103', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Roeselare', 'country': 'Belgium', 'facility': 'Site 101', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Site 202', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Olomouc', 'country': 'Czechia', 'facility': 'Site 203', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Site 201', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Site 302', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Site 301', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Cork', 'country': 'Ireland', 'facility': 'Site 402', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}, {'city': 'Galway', 'country': 'Ireland', 'facility': 'Site 403', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}, {'city': 'Galway', 'country': 'Ireland', 'facility': 'Site 404', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}, {'city': 'Limerick', 'country': 'Ireland', 'facility': 'Site 401', 'geoPoint': {'lat': 52.66472, 'lon': -8.62306}}, {'city': 'Hamar', 'country': 'Norway', 'facility': 'Site 502', 'geoPoint': {'lat': 60.7945, 'lon': 11.06798}}, {'city': 'Skien', 'country': 'Norway', 'facility': 'Site 501', 'geoPoint': {'lat': 59.20962, 'lon': 9.60897}}, {'city': 'Košice', 'country': 'Slovakia', 'facility': 'Site 603', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'city': 'Martin', 'country': 'Slovakia', 'facility': 'Site 602', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Site 702', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Site 701', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Site 704', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Solihull', 'country': 'United Kingdom', 'facility': 'Site 703', 'geoPoint': {'lat': 52.41426, 'lon': -1.78094}}], 'overallOfficials': [{'name': 'Senior Study Manager, Late Phase Clinical Development & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Europe Limited'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}