Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-24 @ 11:59 AM
Study NCT ID:
NCT01225861
Status:
COMPLETED
Last Update Posted:
2014-05-15
First Post:
2010-10-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Study on the Use of Transdermal Analgesic Buprenorphine Patches for Chronic Pain in the UK
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-14', 'studyFirstSubmitDate': '2010-10-20', 'studyFirstSubmitQcDate': '2010-10-20', 'lastUpdatePostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence and severity of side effects', 'timeFrame': 'patients observed for 6 months', 'description': 'Descriptive analysis of incidence and severity of side effects and reasons for discontinuation with Buprenorphine patches. Safety Issue - No'}], 'secondaryOutcomes': [{'measure': 'Treatment patterns', 'timeFrame': 'patients observed for 6 months', 'description': 'Insight into patient profiles treatment patterns and satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '26547914', 'type': 'DERIVED', 'citation': 'Serpell M, Tripathi S, Scherzinger S, Rojas-Farreras S, Oksche A, Wilson M. Assessment of Transdermal Buprenorphine Patches for the Treatment of Chronic Pain in a UK Observational Study. Patient. 2016 Feb;9(1):35-46. doi: 10.1007/s40271-015-0151-y.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is the descriptive analysis of incidence \\& severity of side effects \\& reasons for discontinuation of the treatment of chronic pain with transdermal analgesic Buprenorphine patches.', 'detailedDescription': '750 patients that are treated with transdermal Buprenorphine patches for chronic pain will be included in the study. About 20% of patients are aimed to be patch-naive, ie have received their first prescription of transdermal analgesic patches within 1 month before inclusion in this observational study. Furthermore the study should not include more than 25% of cancer patients that are treated for chronic pain in order to ensure an appropriate mix of patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients experiencing pain. They may be from primary or secondary care.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Patient age \\> 18\n* Patient is treated with transdermal Buprenorphine\n* The patient is able to answer the patient's survey \\& has an estimated overall survival of minimum 6 months\n* The patient gives his/her informed, written consent to participate in the study\n\nExclusion Criteria\n\n* Patient Age \\< 18\n* Patient has less than 6 months survival expectancy\n* Patient is unable to answer the patient survey for whatever reason in any feasible form"}, 'identificationModule': {'nctId': 'NCT01225861', 'briefTitle': 'Prospective Study on the Use of Transdermal Analgesic Buprenorphine Patches for Chronic Pain in the UK', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mundipharma Research Limited'}, 'orgStudyIdInfo': {'id': '241437'}}, 'contactsLocationsModule': {'locations': [{'zip': 'G11 6NT', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Western Infirmary, Terrent Institute', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mundipharma Research Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}