Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-02 @ 8:37 PM
Study NCT ID:
NCT01562834
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2012-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients
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': '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2002-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2012-03-22', 'studyFirstSubmitQcDate': '2012-03-23', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricular mass measured with ultrasonography'}], 'secondaryOutcomes': [{'measure': 'Ventricular function indices assessed by cardiac ultrasonography'}, {'measure': 'Bone mineral density and body composition assessed by DEXA (Dual Energy X-Ray Absorptiometry)'}, {'measure': 'Quality of life using EQ5D (European Quality of Life 5 Dimensions) scales'}, {'measure': 'IGF-I (Insulin-Like Growth Factor I) concentration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Growth Hormone Disorder', 'Adult Growth Hormone Deficiency']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of this trial is to assess the effect of somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients with a growth hormone deficiency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Childhood or adult onset growth hormone deficiency (GHD)\n* GHD evidenced by two stimulation tests\n* Duration of GHD at least 5 years\n* Other hormone deficiencies associated with growth hormone deficiency\n\nExclusion Criteria:\n\n* Pregnancy or pregnancy desired during the suggested duration of the study\n* Personal history of colonic polyp or family history of colonic polyposis\n* Known insulin-dependent or non-insulin-dependent diabetes\n* Cardiovascular disease, left ventricular hypertrophy from other aetiology, recent auricular or ventricular arrhythmia, history of vascularisation by aortocoronary bypass significative mitral or aortic valvular disease, preexcitation syndrome, auriculoventricular conduction delay, bradycardia-tachycardia syndrome, left ventricular mass interfering treatment\n* BMI (Body Mass Index) at least 30\n* Growth hormone treatment during the 24 months prior to inclusion, history of treatment with extractive pituitary growth hormone, allergy or suspected allergy to somatropin therapy\n* Patient who has participated in a different clinical study within the past two months\n* Any condition which, in the opinion of the Investigator or the Scientific Committee, may interfere with successful implementation of the study\n* Notion of breast cancer for the mother or the sister'}, 'identificationModule': {'nctId': 'NCT01562834', 'briefTitle': 'Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Randomized Cross Over Double Blind Versus Placebo Trial Followed by an Open Phase Studying Effect of Norditropin® on Left Ventricular Mass of Growth Hormone Deficient Adult Patients', 'orgStudyIdInfo': {'id': 'GHDADULT/F/1/F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Somatropin', 'interventionNames': ['Drug: somatropin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'somatropin', 'type': 'DRUG', 'description': 'Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months (randomised trial period) followed by an 12-month open-label trial period with somatropin.', 'armGroupLabels': ['Somatropin']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months. After treatment in the randomised trial period, placebo will be discontinued.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49033', 'city': 'Angers', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '76233', 'city': 'Boisguillaume', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '56322', 'city': 'Lorient', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'zip': '69394', 'city': 'Lyon', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13385', 'city': 'Marseille Cédex 05', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06002', 'city': 'Nice', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75571', 'city': 'Paris', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35056', 'city': 'Rennes', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31054', 'city': 'Toulouse', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], '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'}}}}