{"ctNumber":"2022-501892-14-00","ctStatus":"Authorised","startDateEU":"2024-10-14","decisionDate":"2024-03-25T15:53:37.535","publishDate":"2025-02-15T02:09:15.618338441","ctPublicStatusCode":4,"authorizedApplication":{"authorizedPartI":{"id":32468,"rowSubjectCount":0,"products":[{"id":122617,"part1MpRoleTypeCode":"3","productDictionaryInfo":{"euMpNumber":"SUB208557","marketingAuthNumber":"-","prodAuthStatus":2,"prodName":"18F-PSMA-1007","pharmForm":"SOLUTION FOR INJECTION","activeSubstanceName":"18F-PSMA-1007","euSubstNumber":"SUB208557","productSubstances":[{"substancePk":"222446","actSubstOrigin":"Chemical","actSubstName":"18F-PSMA-1007","substanceEvCode":"SUB208557"}],"atcCode":"-","atcName":"-","atcTermLevel":"-","activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"MBq/kg megabecquerel(s)/kilogram","maxDailyDoseAmount":"3.5","doseUomTotal":"MBq/kg megabecquerel(s)/kilogram","maxTotalDoseAmount":"3.5","productChangedRelationMA":false,"maxTreatmentPeriod":1,"timeUnitCode":"1","miaNumber":"5.9.1-2022-084656","scientificProductEvCode":"SUB208557","devices":[],"characteristics":["3"],"routes":["INTRAVENOUS INJECTION"],"allSubstancesChemicals":false,"productName":"18F-PSMA-1007","jsonActiveSubstanceNames":"18f-psma-1007"},{"id":122620,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"10928350","productPharmForm":"INJEKTIONSVÄTSKA, LÖSNING","euMpNumber":"PRD5703691","marketingAuthNumber":"1923","prodAuthStatus":2,"prodName":"Buscopan 20 mg/ml injektionsvätska, lösning","pharmForm":"SOLUTION FOR INJECTION","activeSubstanceName":"HYOSCINE BUTYLBROMIDE","euSubstNumber":"SUB14154MIG","authorisationCountryCode":"FI","nameOrg":"OPELLA HEALTHCARE FRANCE SAS","productSubstances":[{"productPk":"10928350","substancePk":"345568","nameOrg":"OPELLA HEALTHCARE FRANCE SAS","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"HYOSCINE BUTYLBROMIDE","substanceEvCode":"SUB14154MIG","synonyms":["N-BUTYLSCOPOLAMMONIUM BROMIDE","HYOSCINE-N-BUTYL BROMIDE","SCOPOLAMINE N-BUTYL BROMIDE","BUTYLSCOPOLAMINE BROMIDE","HYOSCINE N- BUTYLBROMIDE","SCOPOLAMINE BUTYLBROMIDE","BUTYLHYOSCINE","BUTYLSCOPOLAMINII BROMIDUM"]}],"atcCode":"A03BB01","atcName":"BUTYLSCOPOLAMINE","atcTermLevel":"5","activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"4","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"100","doseUomTotal":"mg milligram(s)","maxTotalDoseAmount":"100","productChangedRelationMA":false,"maxTreatmentPeriod":1,"timeUnitCode":"1","evCode":"PRD5703691","devices":[],"characteristics":[],"routes":["SUBCUTANEOUS"],"allSubstancesChemicals":true,"productName":"Buscopan 20 mg/ml injektionsvätska, lösning","jsonActiveSubstanceNames":"hyoscine butylbromide","pharmaceuticalFormDisplay":"SOLUTION FOR INJECTION"},{"id":122619,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"10904941","productPharmForm":"INJEKTIONSVÄTSKA LÖSNING","euMpNumber":"PRD10904941","marketingAuthNumber":"12086","prodAuthStatus":2,"prodName":"Dotarem 279,3 mg/ml injektionsvätska lösning","pharmForm":"SOLUTION FOR INJECTION","activeSubstanceName":"GADOTERIC ACID","euSubstNumber":"SUB07865MIG","authorisationCountryCode":"FI","nameOrg":"GUERBET","productSubstances":[{"productPk":"10904941","substancePk":"350771","nameOrg":"GUERBET","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"GADOTERIC ACID","substanceEvCode":"SUB07865MIG"}],"atcCode":"V08CA02","atcName":"GADOTERIC ACID","atcTermLevel":"5","activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"4","orphanDrugEdit":false,"doseUom":"ml millilitre(s)","maxDailyDoseAmount":"20","doseUomTotal":"ml millilitre(s)","maxTotalDoseAmount":"20","productChangedRelationMA":false,"maxTreatmentPeriod":1,"timeUnitCode":"1","evCode":"PRD10904941","devices":[],"characteristics":[],"routes":["INTRAVENOUS"],"allSubstancesChemicals":true,"productName":"Dotarem 279,3 mg/ml injektionsvätska lösning","jsonActiveSubstanceNames":"gadoteric acid","pharmaceuticalFormDisplay":"SOLUTION FOR INJECTION"},{"id":122618,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"10211997","productPharmForm":"PULVER OCH VÄTSKA TILL INJEKTIONSVÄTSKA, LÖSNING","euMpNumber":"PRD330295","marketingAuthNumber":"80751","prodAuthStatus":2,"prodName":"Glucagon Novo Nordisk 1 mg pulver och vätska till injektionsvätska, lösning","pharmForm":"SOLUTION FOR INJECTION","activeSubstanceName":"GLUCAGON","euSubstNumber":"SUB02347MIG","authorisationCountryCode":"SE","mrpNumber":"DK/H/0011/001","nameOrg":"NOVO NORDISK A/S","productSubstances":[{"productPk":"10211997","substancePk":"272238","nameOrg":"NOVO NORDISK A/S","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"GLUCAGON","substanceEvCode":"SUB02347MIG"}],"atcCode":"H04AA01","atcName":"GLUCAGON","atcTermLevel":"5","activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"4","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"2","doseUomTotal":"mg milligram(s)","maxTotalDoseAmount":"2","productChangedRelationMA":false,"maxTreatmentPeriod":1,"timeUnitCode":"1","evCode":"PRD330295","devices":[],"characteristics":[],"routes":["INTRAMUSCULAR INJECTION"],"allSubstancesChemicals":false,"productName":"Glucagon Novo Nordisk 1 mg pulver och vätska till injektionsvätska, lösning","jsonActiveSubstanceNames":"glucagon","pharmaceuticalFormDisplay":"SOLUTION FOR INJECTION"}],"trialDetails":{"clinicalTrialIdentifiers":{"fullTitle":"Evaluation of PSMA-PET and mpMRI in high-risk prostate cancer – using histopathologic validation","fullTitleTranslations":[],"publicTitle":"Evaluation of PSMA-PET and mpMRI in high-risk prostate cancer – using histopathologic validation","publicTitleTranslations":[],"shortTitle":"PAMP2","secondaryIdentifyingNumbers":{"additionalRegistries":[]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"5","trialCategory":"2","justificationForTrialCategory":"Phase 3 trial","trialCategoryId":25578},"medicalCondition":{"partIMedicalConditions":[{"id":29846,"medicalCondition":"Prostate cancer","medicalConditionTranslations":[],"isConditionRareDisease":false}],"meddraConditionTerms":[{"termId":100000021147,"version":"20.0","level":"PT","termName":"Prostate cancer","classificationCode":"10060862","organClass":100000004864,"active":false}]},"trialObjective":{"trialScopes":[{"code":"1","trialScopeId":85972}],"mainObjective":"To evaluate and compare the accuracy of PSMA-PET and mpMRI for identification and delineation of the most clinically relevant intra-prostatic lesions or sub-regions.","mainObjectiveTranslations":[],"secondaryObjectives":[{"id":92642,"number":1,"secondaryObjective":"The secondary objective is to study the prognostic potential of PSMA-PET and mpMRI using histopathology as reference standard.","secondaryObjectiveTranslations":[]},{"id":92643,"number":2,"secondaryObjective":"The secondary objective is to study the potential for risk-classification of lesions or subparts of lesions including extracapsular extension and seminal vesicle involvement","secondaryObjectiveTranslations":[]},{"id":92644,"number":3,"secondaryObjective":"The exploratory objective is to study the potential for image processing steps that improve the correlation between histopathology, molecular characteristics, and imaging.","secondaryObjectiveTranslations":[]},{"id":92645,"number":4,"secondaryObjective":"The exploratory objective is to investigate the potential use of machine learning to predict tumour lesions properties from mpMRI and PSMA-PET","secondaryObjectiveTranslations":[]},{"id":92646,"number":5,"secondaryObjective":"The exploratory objective is to investigate the possibility to define these types of lesions in future radiotherapy patients, where they can be subject to a radiotherapy boost, meaning increased dose towards that volume to maximize the probability for curing the patient.","secondaryObjectiveTranslations":[]},{"id":92647,"number":6,"secondaryObjective":"The safety objective is to assess any subject-reported adverse events.","secondaryObjectiveTranslations":[]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":181105,"number":1,"principalInclusionCriteria":"Histologically confirmed high-risk prostate cancer planned to be treated with radical prostatectomy","principalInclusionCriteriaTranslations":[]},{"id":181106,"number":2,"principalInclusionCriteria":"PSMA-PET/CT conducted as part of the clinical management for the existing prostate cancer","principalInclusionCriteriaTranslations":[]},{"id":181107,"number":3,"principalInclusionCriteria":"≥4 weeks since last biopsy of the prostate","principalInclusionCriteriaTranslations":[]},{"id":181108,"number":4,"principalInclusionCriteria":"One or more of the following criteria:    a) cT3, or high suspicion of extra prostatic growth on mpMRI     b) Gleason score ≥8    c) PSA 20-49 ng/ml","principalInclusionCriteriaTranslations":[]},{"id":181109,"number":5,"principalInclusionCriteria":">18 years","principalInclusionCriteriaTranslations":[]},{"id":181110,"number":6,"principalInclusionCriteria":"Given a written consent to participate in the trial","principalInclusionCriteriaTranslations":[]}],"principalExclusionCriteria":[{"id":316545,"number":1,"principalExclusionCriteria":"Non-MR-safe implants or another contraindication to MRI or PET","principalExclusionCriteriaTranslations":[]},{"id":316546,"number":10,"principalExclusionCriteria":"Tinnitus or severe hearing loss","principalExclusionCriteriaTranslations":[]},{"id":316547,"number":2,"principalExclusionCriteria":"Claustrophobia","principalExclusionCriteriaTranslations":[]},{"id":316548,"number":3,"principalExclusionCriteria":"Unfit for MRI or PET/MRI examination for any other reason, e.g., back pain","principalExclusionCriteriaTranslations":[]},{"id":316549,"number":4,"principalExclusionCriteria":"WHO PS >1","principalExclusionCriteriaTranslations":[]},{"id":316550,"number":5,"principalExclusionCriteria":"Patients treated with neoadjuvant/concomitant anti-testosterone treatment (surgical or medical castration such or anti-androgens)","principalExclusionCriteriaTranslations":[]},{"id":316551,"number":6,"principalExclusionCriteria":"TUR-P within 6 months","principalExclusionCriteriaTranslations":[]},{"id":316552,"number":7,"principalExclusionCriteria":"Metastatic disease in skeleton, parenchymal organs, or lymph nodes outside the pelvis.","principalExclusionCriteriaTranslations":[]},{"id":316553,"number":8,"principalExclusionCriteria":"Patients with previous diagnosis of other malignant disease. Exceptions could be made for basal cell carcinoma of the skin or progression free survival at least 10 years after any previous tumor.","principalExclusionCriteriaTranslations":[]},{"id":316554,"number":9,"principalExclusionCriteria":"Creatinine clearance < 30ml/min","principalExclusionCriteriaTranslations":[]}]},"endPoint":{"primaryEndPoints":[{"id":212032,"number":1,"endPoint":"The primary endpoint is spatially defined aggressive PC lesions, or subparts of lesions, identified and defined using PSMA-PET and/or mpMRI compared to histopathology","isPrimary":true,"endPointTranslations":[]}],"secondaryEndPoints":[{"id":212033,"number":1,"endPoint":"The secondary endpoints are biochemical disease-free survival, time to relapse, overall survivor and surgical margins.","isPrimary":false,"endPointTranslations":[]},{"id":212034,"number":2,"endPoint":"The secondary endpoint is to the assess the radiological extracapsular extension and seminal vesicle involvement in comparison to histopathological evaluation.","isPrimary":false,"endPointTranslations":[]},{"id":212035,"number":3,"endPoint":"The exploratory endpoint of the study is also the spatially defined most aggressive PC lesions, or subparts of lesions.","isPrimary":false,"endPointTranslations":[]},{"id":212036,"number":4,"endPoint":"The safety endpoint is subject-reported adverse events up to one week after treatment.","isPrimary":false,"endPointTranslations":[]}]},"trialDuration":{"estimatedEndDate":"2031-12-31","estimatedRecruitmentStartDate":"2024-02-01"},"sourceOfMonetarySupport":[],"populationOfTrialSubjects":{"ageRanges":[{"id":84865,"ageRangeCategoryCode":"4","ageRangeCategory":"4"},{"id":84866,"ageRangeCategoryCode":"3","ageRangeCategory":"3"}],"ageRangeSecondaryIds":[{"id":84867,"ageRangeCategoryCode":"4","ctAgeRangeCode":"7","ctAgeRange":"7","ageRangeCategory":"4"},{"id":84869,"ageRangeCategoryCode":"3","ctAgeRangeCode":"9","ctAgeRange":"9","ageRangeCategory":"3"},{"id":84868,"ageRangeCategoryCode":"4","ctAgeRangeCode":"8","ctAgeRange":"8","ageRangeCategory":"4"}],"clinicalTrialGroups":[{"code":"2","name":"Patients"}],"isFemaleSubjects":false,"isMaleSubjects":true,"isVulnerablePopulationSelected":false},"individualParticipantData":{}},"protocolInformation":{"studyDesign":{"periodDetails":[]}},"scientificAdviceAndPip":{"scientificAdvices":[],"paediatricInvestigationPlan":[]},"associatedClinicalTrials":[],"references":[],"pubmedCode":[],"pubmedUrl":[]},"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-03-25","conclusionDate":"2024-03-25","therapeuticAreas":[{"code":"28","name":"Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]"},{"code":"4","name":"Diseases [C] - Neoplasms [C04]"},{"code":"12","name":"Diseases [C] - Male Urogenital Diseases [C12]"}],"medicalConditions":[{"id":29846,"medicalCondition":"Prostate cancer","isConditionRareDisease":false}],"sponsors":[{"id":34110,"primary":true,"publicContacts":[{"id":92499,"type":"Public","functionalName":"Tufve Nyholm","functionalEmailAddress":"tufve.nyholm@umu.se","telephone":"+46907850000","organisation":{"id":38536,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Region Vasterbotten","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100041239","organisationLocationStatus":"Active"}}],"scientificContacts":[{"id":92500,"type":"Scientific","functionalName":"Tufve Nyholm","functionalEmailAddress":"tufve.nyholm@umu.se","telephone":"+46907850000","organisation":{"id":38536,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Region Vasterbotten","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100041239","organisationLocationStatus":"Active"}}],"thirdParties":[],"legislationComplianceResp":true,"contactPointResp":true,"article77ComplianceResp":true,"organisation":{"id":38536,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Region Vasterbotten","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100041239","organisationLocationStatus":"Active"},"addresses":[{"id":36587,"organisation":{"id":38536,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Region Vasterbotten","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100041239","organisationLocationStatus":"Active"},"address":{"addressId":37893,"oneLine":"Koksvagen 11, Alidhem","addressLine1":"Koksvagen 11","addressLine2":"Alidhem","addressLine3":"","addressLine4":"","city":"Umea","postcode":"907 37","country":2028,"countryName":"Sweden"},"isBusinessKeyValidated":true,"businessKey":"LOC-100067893"}],"isCommercial":false,"commercial":"Non-Commercial"},{"id":34111,"primary":false,"publicContacts":[{"id":92502,"type":"Public","functionalName":"Tufve Nyholm","functionalEmailAddress":"tufve.nyholm@umu.se","telephone":"+46907850000","organisation":{"id":398065,"type":"Educational Institution","typeCode":"1","name":"Umea University","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100030672","organisationLocationStatus":"Active"}}],"scientificContacts":[{"id":92503,"type":"Scientific","functionalName":"Tufve Nyholm","functionalEmailAddress":"tufve.nyholm@umu.se","telephone":"+46907850000","organisation":{"id":398065,"type":"Educational Institution","typeCode":"1","name":"Umea University","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100030672","organisationLocationStatus":"Active"}}],"thirdParties":[],"organisation":{"id":398065,"type":"Educational Institution","typeCode":"1","name":"Umea University","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100030672","organisationLocationStatus":"Active"},"addresses":[{"id":368478,"organisation":{"id":398065,"type":"Educational Institution","typeCode":"1","name":"Umea University","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100030672","organisationLocationStatus":"Active"},"address":{"addressId":393582,"oneLine":"Universitetstorget 4, Alidhem","addressLine1":"Universitetstorget 4","addressLine2":"Alidhem","addressLine3":"","addressLine4":"","city":"Umea","postcode":"907 36","country":2028,"countryName":"Sweden"},"email":"agneta.plamboeck&#64;umu.se","isBusinessKeyValidated":true,"businessKey":"ORG-100030672"}],"isCommercial":false,"commercial":"Non-Commercial"}],"trialCategoryCode":"2","trialCategoryJustificationComment":"Phase 3 trial","partOneTherapeuticAreas":[{"id":342734,"therapeuticArea":{"code":"28","name":"Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]"}},{"id":342736,"therapeuticArea":{"code":"4","name":"Diseases [C] - Neoplasms [C04]"}},{"id":342735,"therapeuticArea":{"code":"12","name":"Diseases [C] - Male Urogenital Diseases [C12]"}}],"productRoleGroupInfos":[{"id":98374,"comments":"18F-PSMA-1007","miaNumber":"5.9.1-2022-084656","productRoleCode":"1","productRoleName":"Test","products":[{"id":122617,"part1MpRoleTypeCode":"3","productDictionaryInfo":{"euMpNumber":"SUB208557","marketingAuthNumber":"-","prodAuthStatus":2,"prodName":"18F-PSMA-1007","pharmForm":"SOLUTION FOR INJECTION","activeSubstanceName":"18F-PSMA-1007","euSubstNumber":"SUB208557","productSubstances":[{"substancePk":"222446","actSubstOrigin":"Chemical","actSubstName":"18F-PSMA-1007","substanceEvCode":"SUB208557"}],"atcCode":"-","atcName":"-","atcTermLevel":"-","activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"MBq/kg megabecquerel(s)/kilogram","maxDailyDoseAmount":"3.5","doseUomTotal":"MBq/kg megabecquerel(s)/kilogram","maxTotalDoseAmount":"3.5","productChangedRelationMA":false,"maxTreatmentPeriod":1,"timeUnitCode":"1","miaNumber":"5.9.1-2022-084656","scientificProductEvCode":"SUB208557","devices":[],"characteristics":["3"],"routes":["INTRAVENOUS INJECTION"],"allSubstancesChemicals":false,"productName":"18F-PSMA-1007","jsonActiveSubstanceNames":"18f-psma-1007"}]},{"id":98375,"comments":"Glucagon Novo Nordisk 1 mg pulver och vätska till injektionsvätska, lösning, Dotarem 279,3 mg/ml injektionsvätska lösning, Buscopan 20 mg/ml injektionsvätska, lösning","productRoleCode":"4","productRoleName":"Auxiliary","products":[{"id":122618,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"10211997","productPharmForm":"PULVER OCH VÄTSKA TILL INJEKTIONSVÄTSKA, LÖSNING","euMpNumber":"PRD330295","marketingAuthNumber":"80751","prodAuthStatus":2,"prodName":"Glucagon Novo Nordisk 1 mg pulver och vätska till injektionsvätska, lösning","pharmForm":"SOLUTION FOR INJECTION","activeSubstanceName":"GLUCAGON","euSubstNumber":"SUB02347MIG","authorisationCountryCode":"SE","mrpNumber":"DK/H/0011/001","nameOrg":"NOVO NORDISK A/S","productSubstances":[{"productPk":"10211997","substancePk":"272238","nameOrg":"NOVO NORDISK A/S","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"GLUCAGON","substanceEvCode":"SUB02347MIG"}],"atcCode":"H04AA01","atcName":"GLUCAGON","atcTermLevel":"5","activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"4","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"2","doseUomTotal":"mg milligram(s)","maxTotalDoseAmount":"2","productChangedRelationMA":false,"maxTreatmentPeriod":1,"timeUnitCode":"1","evCode":"PRD330295","devices":[],"characteristics":[],"routes":["INTRAMUSCULAR INJECTION"],"allSubstancesChemicals":false,"productName":"Glucagon Novo Nordisk 1 mg pulver och vätska till injektionsvätska, lösning","jsonActiveSubstanceNames":"glucagon","pharmaceuticalFormDisplay":"SOLUTION FOR INJECTION"},{"id":122619,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"10904941","productPharmForm":"INJEKTIONSVÄTSKA LÖSNING","euMpNumber":"PRD10904941","marketingAuthNumber":"12086","prodAuthStatus":2,"prodName":"Dotarem 279,3 mg/ml injektionsvätska lösning","pharmForm":"SOLUTION FOR INJECTION","activeSubstanceName":"GADOTERIC ACID","euSubstNumber":"SUB07865MIG","authorisationCountryCode":"FI","nameOrg":"GUERBET","productSubstances":[{"productPk":"10904941","substancePk":"350771","nameOrg":"GUERBET","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"GADOTERIC ACID","substanceEvCode":"SUB07865MIG"}],"atcCode":"V08CA02","atcName":"GADOTERIC ACID","atcTermLevel":"5","activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"4","orphanDrugEdit":false,"doseUom":"ml millilitre(s)","maxDailyDoseAmount":"20","doseUomTotal":"ml millilitre(s)","maxTotalDoseAmount":"20","productChangedRelationMA":false,"maxTreatmentPeriod":1,"timeUnitCode":"1","evCode":"PRD10904941","devices":[],"characteristics":[],"routes":["INTRAVENOUS"],"allSubstancesChemicals":true,"productName":"Dotarem 279,3 mg/ml injektionsvätska lösning","jsonActiveSubstanceNames":"gadoteric acid","pharmaceuticalFormDisplay":"SOLUTION FOR INJECTION"},{"id":122620,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"10928350","productPharmForm":"INJEKTIONSVÄTSKA, LÖSNING","euMpNumber":"PRD5703691","marketingAuthNumber":"1923","prodAuthStatus":2,"prodName":"Buscopan 20 mg/ml injektionsvätska, lösning","pharmForm":"SOLUTION FOR INJECTION","activeSubstanceName":"HYOSCINE BUTYLBROMIDE","euSubstNumber":"SUB14154MIG","authorisationCountryCode":"FI","nameOrg":"OPELLA HEALTHCARE FRANCE SAS","productSubstances":[{"productPk":"10928350","substancePk":"345568","nameOrg":"OPELLA HEALTHCARE FRANCE SAS","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"HYOSCINE BUTYLBROMIDE","substanceEvCode":"SUB14154MIG","synonyms":["N-BUTYLSCOPOLAMMONIUM BROMIDE","HYOSCINE-N-BUTYL BROMIDE","SCOPOLAMINE N-BUTYL BROMIDE","BUTYLSCOPOLAMINE BROMIDE","HYOSCINE N- BUTYLBROMIDE","SCOPOLAMINE BUTYLBROMIDE","BUTYLHYOSCINE","BUTYLSCOPOLAMINII BROMIDUM"]}],"atcCode":"A03BB01","atcName":"BUTYLSCOPOLAMINE","atcTermLevel":"5","activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"4","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"100","doseUomTotal":"mg milligram(s)","maxTotalDoseAmount":"100","productChangedRelationMA":false,"maxTreatmentPeriod":1,"timeUnitCode":"1","evCode":"PRD5703691","devices":[],"characteristics":[],"routes":["SUBCUTANEOUS"],"allSubstancesChemicals":true,"productName":"Buscopan 20 mg/ml injektionsvätska, lösning","jsonActiveSubstanceNames":"hyoscine butylbromide","pharmaceuticalFormDisplay":"SOLUTION FOR INJECTION"}]}],"isLowIntervention":false},"authorizedPartsII":[{"id":77485,"mscId":7197,"mscInfo":{"id":7197,"clinicalTrialId":2028,"countryOrganisationId":2028,"reportingStatusCode":"Authorised","fromDate":"2024-03-05","toDate":"2024-03-05","isProposedRms":true,"countryName":"Sweden","organisationInfo":{},"firstDecisionDate":"2024-03-25","trialStatus":"Authorised","trialPeriod":[{"id":39107,"trialStartDate":"2024-10-18","fromDate":"2024-10-18"},{"id":39532,"trialStartDate":"2024-10-14","fromDate":"2024-10-22"},{"id":39108,"trialStartDate":"2024-10-18","fromDate":"2024-10-18"},{"id":39109,"trialStartDate":"2024-10-18","fromDate":"2024-10-18"}],"trialRecruitmentPeriod":[{"id":51719,"recruitmentStartDate":"2024-10-14","fromDate":"2024-10-22"},{"id":51720,"recruitmentStartDate":"2024-10-14","fromDate":"2024-10-22"},{"id":51185,"recruitmentStartDate":"2024-10-18","fromDate":"2024-10-18"},{"id":51186,"recruitmentStartDate":"2024-10-18","fromDate":"2024-10-18"}],"hasRecruitmentStarted":true,"activeTrialPeriod":{"id":53226,"trialStartDate":"2024-10-14","fromDate":"2024-10-22"},"activeTrialRecruitmentPeriod":{"recruitmentStartDate":"2024-10-14"},"isWillingAtDayThreeView":false,"clinicalTrialStatusHistory":[{"id":19374,"mscId":7197,"trialStatus":"Under evaluation","trialStatusDate":"2023-12-20T10:55:31.024"},{"id":28018,"mscId":7197,"trialStatus":"Authorised","trialStatusDate":"2024-03-25T15:53:37.329"}],"applicationTypeMsc":"1","mscName":"Sweden","assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-03-25","decision":"authorized","decisionDate":"2024-03-25"},"decisionDate":"2024-03-25","recruitmentSubjectCount":20,"trialSites":[{"id":497102,"organisationAddressInfo":{"id":197553,"organisation":{"id":201104,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Region Vaesterbotten","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100041239","organisationLocationStatus":"Active"},"address":{"addressId":209882,"oneLine":"Koksvagen 11, Alidhem","addressLine1":"Koksvagen 11","addressLine2":"Alidhem","addressLine3":"","addressLine4":"","city":"Umea","postcode":"907 37","country":2028,"countryName":"Sweden"},"phone":"+46907850000","email":"camilla.thellenberg@umu.se","isBusinessKeyValidated":true,"businessKey":"LOC-100067893"},"personInfo":{"id":561984,"firstName":"Camilla","lastName":"Thellenberg Karlsson","telephone":"+46907850000","email":"camilla.thellenberg@umu.se","title":"1"},"departmentName":"Cancercentrum"}],"applicationStatusCode":"Authorised"}],"applicationInfo":[{"id":2119,"type":"INITIAL","status":"Authorised","ctNumber":"2022-501892-14-00","trialStatus":"Authorised","submissionDate":"2023-12-20","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-03-25"},"partIIInfo":[{"id":77485,"mscId":7197,"mscInfo":{"id":7197,"mscName":"Sweden","countryOrganisationId":2028,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-03-25","decision":"authorized","decisionDate":"2024-03-25","reportingStatusCode":"Authorised","countryName":"Sweden","trialStatus":"Authorised","firstDecisionDate":"2024-03-25"},"applicationStatusCode":"Authorised"}],"decisionDate":"2024-03-25","ctMSCsByApplication":[{"id":7197,"mscName":"Sweden","reportingStatusCode":"Authorised"}],"businessKey":"IN","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":16779,"applicationId":2119,"mscId":7197,"mscName":"Sweden","decisionDate":"2024-03-25T15:53:37.535","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":77485,"part1Id":32468,"applicationType":"INITIAL","isRMS":true}]}],"trialGlobalEnd":[],"memberStatesConcerned":[{"mscName":"Sweden","mscId":7197,"firstDecisionDate":"2024-03-25T15:53:37.535","lastDecisionDate":"2024-03-25T15:53:37.535","mscPublicStatusCode":4}],"eudraCt":{"isTransitioned":false}},"events":{"temporaryHaltList":[],"trialEvents":[{"mscId":7197,"mscName":"Sweden","events":[{"notificationType":"START_OF_TRIAL","date":"2024-10-14"},{"notificationType":"START_OF_RECRUITMENT","date":"2024-10-14"}]}],"unexpectedEvents":[],"seriousBreaches":[],"urgentSafetyMeasures":[]},"results":{},"documents":[],"trialRegion":"EEA","trialRegionCode":1,"correctiveMeasures":[]}