Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT00446069
Status:
COMPLETED
Last Update Posted:
2016-08-29
First Post:
2007-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Efficacy and Safety Trial of Controlled Release (CR) Morphine in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-26', 'studyFirstSubmitDate': '2007-03-09', 'studyFirstSubmitQcDate': '2007-03-09', 'lastUpdatePostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Use of rescue medication', 'timeFrame': '2 weeks treatment'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '2 weeks treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain', 'Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the effect of Egalet® Morphine once daily compared to MST Continus twice daily on pain intensity and use of rescue medication for break through pain after 2 weeks of treatment in patients with pain due to cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient has stable strong opioid use equipotent to 30-240 mg oral morphine sulphate daily for a minimum of 2 weeks prior to entering the run-in phase.\n* The patient has opioid-sensitive pain caused by active cancer.\n* The patient is aged minimum 18 years.\n\nExclusion Criteria:\n\n* The patient has a life expectancy less than 2 months.\n* The patient has received chemotherapy or radiation therapy less than 4 weeks prior to entering run-in phase\n* Patients with medical conditions contraindicating morphine treatment\n* The patient has hepatic disease or impaired kidney function\n* The patient is taking monoamine oxidase inhibitors (MAOIs) or has taken a MAOI within two weeks prior to entering baseline.\n* The patient is taking other opioid agonists or antagonists, zidovudine or cimetidine.'}, 'identificationModule': {'nctId': 'NCT00446069', 'briefTitle': 'A Efficacy and Safety Trial of Controlled Release (CR) Morphine in Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Egalet Ltd'}, 'officialTitle': 'A Double-blind, Randomized, 2-way Cross-over, Phase II, Efficacy Trial in Cancer Patients to Assess the Overall Efficacy, Patient Preference, Morphine Related Side Effect Profile and Safety of the Egalet® Controlled Release Morphine Formulation 30-240 mg Once Daily Compared to MST Continus® 15-120 mg Twice Daily After 2 Weeks of Treatment', 'orgStudyIdInfo': {'id': 'MP-EG-002'}, 'secondaryIdInfos': [{'id': 'EudraCT number: 2006-006579-19'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Egalet® morphine', 'interventionNames': ['Drug: Morphine Sulphate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MST Continus®', 'interventionNames': ['Drug: Morphine Sulphate']}], 'interventions': [{'name': 'Morphine Sulphate', 'type': 'DRUG', 'description': 'Egalet® morphine, Controlled Release 30 mg Oral tablet once daily for 2 weeks and MST Continus® 15 mg twice daily for 2 weeks', 'armGroupLabels': ['Egalet® morphine', 'MST Continus®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Site 51', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Site 50', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'Bielsko-Biaia', 'country': 'Poland', 'facility': 'Site 63'}, {'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Site 60', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Site 62', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Site 61', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Site 64', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Włocławek', 'country': 'Poland', 'facility': 'Site 65', 'geoPoint': {'lat': 52.64817, 'lon': 19.0678}}], 'overallOfficials': [{'name': 'Christine Andersen, MSc Pharm', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Egalet A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Egalet Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}