Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-26 @ 12:32 AM
Study NCT ID:
NCT00145457
Status:
COMPLETED
Last Update Posted:
2007-06-06
First Post:
2005-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IGF1 Generation Test
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': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2005-01'}, 'lastUpdateSubmitDate': '2007-06-05', 'studyFirstSubmitDate': '2005-09-01', 'studyFirstSubmitQcDate': '2005-09-01', 'lastUpdatePostDateStruct': {'date': '2007-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of height standard deviation score after 24 months of treatment according to the short term response of plasma IGF1 to Genotonorm.'}]}, 'conditionsModule': {'conditions': ['Growth Hormone Deficiency']}, 'descriptionModule': {'briefSummary': 'To assess the predictive value of the short term IGF-1 stimulation test, based on IGF-1 changes, on the 24 months growth response to 2 different doses of GH in patients with conventional GH deficiency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged of more than 4 years.\n* GHD defined as a peak GH level \\< 20 mUI/ml at two different pharmacological GH provocative tests including one done with two pharmacological agents and both performed within the year before the inclusion, according to the current recommendations of the French Health Authorities\n\nExclusion Criteria:\n\n* Previous treatment with GH\n* Ongoing pharmacological treatment with steroids except if corresponding to substitutive therapy'}, 'identificationModule': {'nctId': 'NCT00145457', 'acronym': 'CAREL', 'briefTitle': 'IGF1 Generation Test', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multicentre Study on the Capacity of the IGF-1 Stimulation Test to Predict the Growth Promoting Effect of Standard and High Doses of Genotonorm® in Prepubertal Children With Growth Hormone Deficiency.', 'orgStudyIdInfo': {'id': '307-MET-9002-040'}, 'secondaryIdInfos': [{'id': 'A6281023'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood sample', 'type': 'PROCEDURE'}, {'name': 'Radiography', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Pfizer Investigational Site'}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '59385', 'city': 'Dunkirk', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.0344, 'lon': 2.37681}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75674', 'city': 'Paris', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '65013', 'city': 'Tarbes', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.23407, 'lon': 0.07139}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}}}}