Viewing Study NCT00184756


Ignite Creation Date: 2025-12-24 @ 11:37 PM
Ignite Modification Date: 2025-12-25 @ 9:27 PM
Study NCT ID: NCT00184756
Status: COMPLETED
Last Update Posted: 2017-01-13
First Post: 2005-09-13
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Efficacy on Height in SGA Children Treated With Growth Hormone
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-12', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate effect on Height in SGA Children Treated with Growth Hormone', 'timeFrame': 'After 2 years of treatment'}], 'secondaryOutcomes': [{'measure': 'Appetite'}, {'measure': 'Height SDS, yearly'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Foetal Growth Problem', 'Small for Gestational Age']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Phillip M, Lebl J, Zuckerman-Levin N, Korpal-Szczyrska M, Sales Marques J, Ibáñez L on behalf of the European Norditropin SGA study group. Multinational study in short SGA children: evaluation of the effect of three different growth hormone dose regimens. European Society for Paediatric Endocrinology (ESPE) 2007; Country: Finland City: Helsinki'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial compares a treated group of patients with an untreated group of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Born small for gestational age with length and/or weight at -2 SDS or below at time of birth, according to country specific references.\n* Severe growth failure with no catch up and with height at -2.5 SDS or below, according to country specific references, for chronological age at time of inclusion\n\nExclusion Criteria:\n\n* Growth Hormone Deficiency (GHD)\n* Treatment with any medical product which may interfere with GH effects\n* Growth retardation associated with infections, severe chronic diseases including chromosomal anomaly or nutritional disorders'}, 'identificationModule': {'nctId': 'NCT00184756', 'briefTitle': 'Efficacy on Height in SGA Children Treated With Growth Hormone', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Effect of Two Years Treatment With Growth Hormone on Height in SGA Children.', 'orgStudyIdInfo': {'id': 'GHLIQUID-1424'}}, 'armsInterventionsModule': {'interventions': [{'name': 'somatropin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '61300', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '77520', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '10081', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '116 94', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '15006', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '40011', 'city': 'Usti N. 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