Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT01578135
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2012-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
French National Registry of Children Born Small for Gestational Age Treated With Somatropin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006130', 'term': 'Growth Disorders'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019382', 'term': 'Human Growth Hormone'}], 'ancestors': [{'id': 'D013006', 'term': 'Growth Hormone'}, {'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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 291}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-19', 'studyFirstSubmitDate': '2012-04-13', 'studyFirstSubmitQcDate': '2012-04-13', 'lastUpdatePostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Growth in height', 'timeFrame': '6 months after inclusion into registry and then annually until adult height is reached'}], 'secondaryOutcomes': [{'measure': 'Blood pressure: Systolic and diastolic', 'timeFrame': '6 months after inclusion into registry and then annually until adult height is reached'}, {'measure': 'Bone age', 'timeFrame': '6 months after inclusion into registry and then annually until adult height is reached'}, {'measure': 'Insulin-Like Growth Factor 1 (IGF-1)', 'timeFrame': '6 months after inclusion into registry and then annually until adult height is reached'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Growth Disorder', 'Small for Gestational Age']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in Europe. The aim of the study is to describe the patient population and therapeutic practices (study phase I), assess efficacy on growth and adult height and assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Phase I: All patients born SGA treated with Norditropin® SimpleXx® (somatropin) whether they were previously treated with another growth hormone for this indication or not from the 29th of April 2005 until 29th of April 2010.\n\nPhase II: Sub-population randomly selected (every 5th patient being included in registry in study phase I).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Born small for gestational age'}, 'identificationModule': {'nctId': 'NCT01578135', 'briefTitle': 'French National Registry of Children Born Small for Gestational Age Treated With Somatropin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'French National Longitudinal Prospective Follow-up of Children Born Small for Gestational Age and Treated With Norditropin SimpleXx (French Health Authorities Commitment)', 'orgStudyIdInfo': {'id': 'GHSGA-1757'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Phase I', 'interventionNames': ['Drug: somatropin']}, {'label': 'Phase II', 'interventionNames': ['Drug: somatropin']}], 'interventions': [{'name': 'somatropin', 'type': 'DRUG', 'description': 'Patients are to fill in a questionnaire at inclusion in registry', 'armGroupLabels': ['Phase I']}, {'name': 'somatropin', 'type': 'DRUG', 'description': 'Patients are to fill in a questionnaire 6 months after inclusion into registry and then annually until adult height is reached', 'armGroupLabels': ['Phase II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92936', 'city': 'Paris La Défense', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site'}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}