Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-29 @ 12:11 AM
Study NCT ID:
NCT01842893
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2013-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059390', 'term': 'Breakthrough Pain'}, {'id': 'D009369', 'term': 'Neoplasms'}], '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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-02', 'studyFirstSubmitDate': '2013-04-18', 'studyFirstSubmitQcDate': '2013-04-29', 'lastUpdatePostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Summed Pain Intensity Difference at 30 minutes (SPID30).', 'timeFrame': '30 minutes post dose'}], 'secondaryOutcomes': [{'measure': 'SPID at 3, 6, 10, 15 and 60 minutes post-dosing', 'timeFrame': '3, 6, 10, 15 and 60 minutes post-dosing'}, {'measure': 'SPID at 15 and 30 minutes according to the pathophysiology of the pain (neuropathic, nociceptive)', 'timeFrame': '15 and 30 minutes post dose'}, {'measure': 'Pain Intensity Difference at 3, 6, 10, 15, 30 and 60 minutes after dosing', 'timeFrame': '3, 6, 10, 15, 30 and 60 minutes after dosing'}, {'measure': 'Pain Relief at 3, 6, 10, 15, 30 and 60 minutes after dosing', 'timeFrame': '3, 6, 10, 15, 30 and 60 minutes after dosing'}, {'measure': 'The proportion of episodes of BTP that required rescue medication', 'timeFrame': '15 and 30 minutes post dose'}, {'measure': 'the proportion of episodes with more than 33% and 50% of improvement in Pain Intensity scores', 'timeFrame': '15 and 30 minutes post dose'}, {'measure': 'Recording of safety data', 'timeFrame': 'During all the study duration, an expected average of 8 weeks', 'description': 'Adverse events, vital signs, urinary pregnancy test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fentanyl', 'breakthrough pain', 'opioid treated cancer patients'], 'conditions': ['Breakthrough Pain', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '24508417', 'type': 'DERIVED', 'citation': 'Novotna S, Valentova K, Fricova J, Richterova E, Harabisova S, Bullier F, Trinquet F; ETHYFYL Study Group. A randomized, placebo-controlled study of a new sublingual formulation of fentanyl citrate (fentanyl ethypharm) for breakthrough pain in opioid-treated patients with cancer. Clin Ther. 2014 Mar 1;36(3):357-67. doi: 10.1016/j.clinthera.2014.01.006. Epub 2014 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the clinical effectiveness of Fentanyl ETHYPHARM when used to relieve breakthrough pain (BTP) in opioid-treated cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Written informed consent\n2. Malignant solid tumor or a hematological malignancy causing cancer-related pain\n3. Background opioid treatment at a stable dose for at least a week\n4. One to four episodes of breakthrough pain per day\n\nMain exclusion criteria:\n\n1. Hypersensitivity to fentanyl or to any of the excipients\n2. Intrathecal opioids\n3. Recent history of substance abuse\n4. Recent or planned therapy that would alter pain\n5. Moderate or severe hepatic or renal disease'}, 'identificationModule': {'nctId': 'NCT01842893', 'acronym': 'ETHYFYL', 'briefTitle': 'Efficacy and Safety of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ethypharm'}, 'officialTitle': 'Randomized, Placebo-controlled Study of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer', 'orgStudyIdInfo': {'id': 'FYL/24019/008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fentanyl / Placebo', 'description': 'After an open-label titration to identify an optimal dose, patients were randomized to 1 of 13 prespecified sequences of 9 tablets (6 fentanyl and 3 placebo)', 'interventionNames': ['Drug: Fentanyl Ethypharm']}], 'interventions': [{'name': 'Fentanyl Ethypharm', 'type': 'DRUG', 'description': 'After an open-label titration to identify an optimal dose, patients were randomized to 1 of 13 prespecified sequences of 9 tablets (6 fentanyl and 3 placebo)', 'armGroupLabels': ['Fentanyl / Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Prague', 'country': 'Czechia', 'facility': 'Pain Care Units', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ethypharm', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}