Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT01365351
Status:
COMPLETED
Last Update Posted:
2017-06-02
First Post:
2011-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Online Surveillance of Treatment of Children With Growth Hormone Deficiency With ZOMACTON
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004393', 'term': 'Dwarfism, Pituitary'}], 'ancestors': [{'id': 'D004392', 'term': 'Dwarfism'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D007018', 'term': 'Hypopituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013006', 'term': 'Growth Hormone'}], 'ancestors': [{'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1034}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-01', 'studyFirstSubmitDate': '2011-06-01', 'studyFirstSubmitQcDate': '2011-06-02', 'lastUpdatePostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of ZOMACTON', 'timeFrame': 'Up to 5 years', 'description': 'measured by: body height, increase of body height per annum'}], 'secondaryOutcomes': [{'measure': 'Efficacy measured by further parameters', 'timeFrame': 'Up to 5 years', 'description': 'measured by: weight, increase weight per annum sitting height, increase of sitting height per annum head circumference per annum bone age, increase of bone age per annum puberty development IGF-1, IGFBP-3 psychological cofactors'}, {'measure': 'Safety of Zomacton and application device', 'timeFrame': 'Up to 5 years', 'description': 'measured by: local adverse reactions to the application device adverse events of Zomacton safety laboratory'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Growth Hormone Deficiency']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Clinics and private practices', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* therapeutic need according to SPC\n* written informed consent\n\nExclusion Criteria:\n\n* contraindications according to SPC'}, 'identificationModule': {'nctId': 'NCT01365351', 'briefTitle': 'Online Surveillance of Treatment of Children With Growth Hormone Deficiency With ZOMACTON', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'Non-interventional Study With ZOMACTON in Children With Growth Hormone Deficiency', 'orgStudyIdInfo': {'id': 'ZOM/011207/03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Growth hormone', 'description': 'Children with growth hormone deficiency', 'interventionNames': ['Other: Growth hormone']}], 'interventions': [{'name': 'Growth hormone', 'type': 'OTHER', 'description': 'Drug given by prescription', 'armGroupLabels': ['Growth hormone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Konrad-Adenauer-Allee 33', 'state': 'Augsburg', 'country': 'Germany', 'facility': 'Investigational Site'}, {'city': 'Friedrichstr. 36-42', 'state': 'Dresden', 'country': 'Germany', 'facility': 'Investigational Site'}, {'city': 'Blücherstr. 4', 'state': 'Erfurt', 'country': 'Germany', 'facility': 'Investigational Site'}, {'city': 'Loschgestr. 15', 'state': 'Erlangen', 'country': 'Germany', 'facility': 'Investigational Site'}, {'city': 'Düsseldorfer Str. 1-7', 'state': 'Frankfurt (Main)', 'country': 'Germany', 'facility': 'Investigational Site'}, {'city': 'Stresemannallee 1-3', 'state': 'Frankfurt (Main)', 'country': 'Germany', 'facility': 'Investigational Site'}, {'city': 'Wilhelm-Breckow-Allee 20', 'state': 'Gummersbach', 'country': 'Germany', 'facility': 'Investigational Site'}, {'city': 'Seminarstr. 2', 'state': 'Heidelberg', 'country': 'Germany', 'facility': 'Investigational Site'}, {'city': 'Koblenzer Str. 115-155', 'state': 'Koblenz', 'country': 'Germany', 'facility': 'Investigational Site'}, {'city': 'Elisenstr. 12', 'state': 'Oldenburg', 'country': 'Germany', 'facility': 'Investigational Site'}, {'city': 'Elisabethenstr. 15', 'state': 'Ravensburg', 'country': 'Germany', 'facility': 'Investigational Site'}, {'city': 'Chausseestr. 119', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Investigational Site'}, {'city': 'Marienstr. 6-8', 'state': 'Vechta', 'country': 'Germany', 'facility': 'Investigational Site'}, {'city': 'Bad Langensalza', 'country': 'Germany', 'facility': 'Investigational Site, Geranienweg 7', 'geoPoint': {'lat': 51.10771, 'lon': 10.646}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigational Site, Augustenburger Platz 1', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigational Site, Chausseestraße 119', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigational Site. 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'facility': 'Investigational Site, Fetscherstraße 74', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Düren', 'country': 'Germany', 'facility': 'Investigational Site, Hospitalstraße 44', 'geoPoint': {'lat': 50.80434, 'lon': 6.49299}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Investigational Site, Düsseldorfer Straße 8', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Investigational Site, Hufelandstraße 55', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Investigational Site, Lyoner Straße 54', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Investigational Site, Mathildenstraße 1', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Gauting', 'country': 'Germany', 'facility': 'Investigational Site, Pippinplatz 4', 'geoPoint': {'lat': 48.06919, 'lon': 11.37703}}, {'city': 'Gehrden', 'country': 'Germany', 'facility': 'Investigational Site, Am Markt 3', 'geoPoint': {'lat': 52.31362, 'lon': 9.60033}}, {'city': 'Göttingen', 'country': 'Germany', 'facility': 'Investigational Site, Robert-Koch-Straße 40', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Halle', 'country': 'Germany', 'facility': 'Investigational Site, Ernst-Grube-Straße 40', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Investigational Site, Bleickenallee 38-40', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Investigational Site, Lornsenstraße 4-6', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamm', 'country': 'Germany', 'facility': 'Investigational Site, Werlerstraße 130', 'geoPoint': {'lat': 51.68033, 'lon': 7.82089}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Investigational Site, Brabeckstraße 153', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Investigational Site, Im Neuenheimer Feld 430', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Investigational Site, Seminarstraße 2', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Homburg', 'country': 'Germany', 'facility': 'Investigational Site, Kirrberger Straße', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'city': 'Jena', 'country': 'Germany', 'facility': 'Investigational Site, Kochstraße 2', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'Investigational Site, Ettlinger Straße 27', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'city': 'Kiel', 'country': 'Germany', 'facility': 'Investigational Site, Schwanenweg 20', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Koblenz', 'country': 'Germany', 'facility': 'Investigational Site, Koblenzer Str. 115-155', 'geoPoint': {'lat': 50.35357, 'lon': 7.57883}}, {'city': 'Krefeld', 'country': 'Germany', 'facility': 'Investigational Site, Lutherplatz 40', 'geoPoint': {'lat': 51.33645, 'lon': 6.55381}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Investigational Site, Johannisplatz 1', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Investigational Site, Liebigstraße 20 a', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Investigational Site, Birkenallee 34', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Investigational Site, Leipziger Straße 44', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'city': 'München', 'country': 'Germany', 'facility': 'Investigational Site, Kölner Platz 1', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'München', 'country': 'Germany', 'facility': 'Investigational Site, 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'country': 'Germany', 'facility': 'Investigational Site, Pettenkoferstraße 10', 'geoPoint': {'lat': 47.85637, 'lon': 12.12247}}, {'city': 'Ulm', 'country': 'Germany', 'facility': 'Investigational Site, Eythstraße 24', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ferring Arzneimittel GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}