[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100229762":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":12,"collaborators":10,"id":14,"slug":15,"hasResults":16,"nctId":17,"briefTitle":18,"officialTitle":19,"acronym":20,"eligibilityCriteria":21,"healthyVolunteers":22,"sex":23,"minAge":24,"maxAge":10,"enrollmentInfo":25,"targetDuration":10,"studyType":28,"phases":10,"briefSummary":29,"conditions":30,"keywords":33,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":10},{"fullName":5,"class":6},"Eisai Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Ziconotide",null,"No drug will be provided by the sponsor. Treatment decisions will be made by physicians independent of participation in the registry.\n\nIT analgesia may consist of ziconotide or any other drug used in IT therapy, including those used off-label as part of local clinical practice.",{"type":13,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100229762","patient-registry-of-intrathecal-pain-management-in-europe-for-prialt-ziconotide-intrathecal-infusion-and-alternative-drugs-for-the-management-of-severe-chronic-pain-100229762",true,"NCT02268812","Patient Registry of Intrathecal Pain Management in Europe for Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.","Patient Registry of Intrathecal Pain Management in Europe: An Open-label, Long-term, Multi-center, Multi-national Post-marketing Observational Study of the Use of Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.","PRIME","Inclusion Criteria\n\nPatients will be eligible to enroll onto the registry if they have given informed consent and meet the following criteria:\n\n* Patient's physician has deemed that the initiation\u002Fswitch of intrathecal analgesia appropriate, or patient is presently utilizing ziconotide (Prialt)\n* Patient has a diagnosis of severe, chronic pain for which intrathecal infusion is indicated\n* Patient is at least 18 years of age at time of study entry\n\nAll patients starting ziconotide (Prialt) should comply with the indications and warnings in the current approved version of the Summary of Product Characteristics (SmPC).\n\nExclusion Criteria\n\nPatients who meet any of the following criteria will not be eligible to enroll in the registry:\n\n* Patient is a pregnant or lactating female\n* Patient is receiving intrathecal chemotherapy",false,"ALL","18 Years",{"count":26,"type":27},219,"ACTUAL","OBSERVATIONAL","This is an open-label, long-term, multi-center multi-national post-marketing observational registry. The objective of this study is to monitor the long-term efficacy, safety, tolerability and quality of life outcomes associated with ziconotide (Prialt) and other analgesics utilized in the intrathecal (IT) management of severe chronic pain.",[31,32],"Pain Management","Severe Chronic Pain",[31,34,35],"Europe","Intrathecal","COMPLETED","2018-01-05",{"date":39,"type":27},"2018-10-25",{"date":41,"type":10},"2008-04",{"date":43,"type":27},"2012-07",{"name":45,"class":6},"Eisai Limited"]