Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-01-04 @ 1:41 PM
Study NCT ID:
NCT00496392
Status:
COMPLETED
Last Update Posted:
2012-05-07
First Post:
2007-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq) in Cancer Breakthrough Pain (FT-019-IM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-04', 'studyFirstSubmitDate': '2007-07-03', 'studyFirstSubmitQcDate': '2007-07-03', 'lastUpdatePostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary endpoint: Time to onset of meaningful pain relief recorded by stopwatch', 'timeFrame': '26 weeks'}], 'secondaryOutcomes': [{'measure': '• Pain Intensity Differences (PID) at 10 and 30 min derived from Pain Intensity (PI) scores • Sum of Pain Intensity Differences (SPID) 0-15 and 0-60 derived from PI scores • Time to 50% reduction in PI scores • General impression (GI) of the t', 'timeFrame': '26 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breakthrough pain in patients with cancer'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '19792837', 'type': 'DERIVED', 'citation': 'Mercadante S, Radbruch L, Davies A, Poulain P, Sitte T, Perkins P, Colberg T, Camba MA. A comparison of intranasal fentanyl spray with oral transmucosal fentanyl citrate for the treatment of breakthrough cancer pain: an open-label, randomised, crossover trial. Curr Med Res Opin. 2009 Nov;25(11):2805-15. doi: 10.1185/03007990903336135.'}]}, 'descriptionModule': {'briefSummary': "Primary:\n\n• To compare the efficacy of nasal fentanyl (NF) to oral transmucosal fentanyl (Actiq®) (hereafter Actiq) in the management of breakthrough pain in cancer patients.\n\nSecondary:\n\n* To compare patients' general impression and preference of NF and Actiq\n* To explore the relationship between NF doses and dose of current opioid for breakthrough pain (BTP) and the relationship between dose of NF and of background opioid\n* To assess safety and tolerability of NF"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult in- or out patient with cancer and breakthrough pain; using a stable, chronic opioid treatment for background pain.\n* Minimum three BTP episodes per week and maximum four per day. Life expectancy of at least three months.\n* Chemotherapy and palliative radiotherapy (except facial radiotherapy) are allowed.\n* Randomisation in previous studies with NF, i.e. FT-016-IM, FT-017-IM or FT-018-IM, is not allowed.\n* Previous use of Actiq is accepted.'}, 'identificationModule': {'nctId': 'NCT00496392', 'briefTitle': 'Comparison of Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq) in Cancer Breakthrough Pain (FT-019-IM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nycomed'}, 'officialTitle': 'An Open Label, Comparative, Randomised, Balanced Crossover Trial Comparing Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq®) in Breakthrough Pain in Patients With Cancer', 'orgStudyIdInfo': {'id': 'FT-019-IM'}, 'secondaryIdInfos': [{'id': '2006-002087-26'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Nasal fentanyl', 'type': 'DRUG', 'otherNames': ['Instanyl'], 'description': 'Breakthrough pain in patients with breast or prostate cancer'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Roskilde', 'country': 'Denmark', 'facility': 'Nycomed', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}], 'overallOfficials': [{'name': 'Nycomed Clinical Trial Operations', 'role': 'STUDY_CHAIR', 'affiliation': 'Headquaters'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nycomed', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Nycomed', 'oldOrganization': 'Nycomed'}}}}