Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT00190658
Status:
COMPLETED
Last Update Posted:
2010-12-20
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005183', 'term': 'Failure to Thrive'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019382', 'term': 'Human Growth Hormone'}, {'id': 'D000074584', 'term': 'WW Domain-Containing Oxidoreductase'}], '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'}, {'id': 'D000074583', 'term': 'Short Chain Dehydrogenase-Reductases'}, {'id': 'D064430', 'term': 'NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases'}, {'id': 'D000429', 'term': 'Alcohol Oxidoreductases'}, {'id': 'D010088', 'term': 'Oxidoreductases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D025521', 'term': 'Tumor Suppressor Proteins'}, {'id': 'D009363', 'term': 'Neoplasm Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-02'}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-17', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2010-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of first year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.'}], 'secondaryOutcomes': [{'measure': 'Comparison of second year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.'}, {'measure': 'Non inferiority to somatropin treated patients with Turner syndrome'}, {'measure': 'Adult height of treated patients'}]}, 'conditionsModule': {'conditions': ['Failure to Thrive']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial will compare the mean first year height velocity of somatropin-treated prepubertal patients with SHOX deficiency with the height velocity of a control group of untreated prepubertal patients with SHOX deficiency. Both groups will be compared to a somatropin-treated group of girls with Turner syndrome. After the second year patients in the control group have the option to receive treatment as well. All patients will optionally be treated until they achieved adult height.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Turner Syndrome or SHOX disorder\n* SHOX: bone age greater than 10 years for boys, greater than 8 years for girls, Turner: bone age greater than 9 years\n* Height below 3rd percentile or height below 10th percentile and growth velocity below 25th percentile\n* Prepubertal: For girls, Tanner stage 1, for boys Tanner stage 1 and testicular volume no more than 2 mL\n\nExclusion Criteria:\n\n* GH deficiency or known insensitivity\n* Evidence of tumor activity\n* Diabetes mellitus or history of impaired glucose tolerance\n* Any severe illness known to interfere growth'}, 'identificationModule': {'nctId': 'NCT00190658', 'briefTitle': 'Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Safety and Efficacy of Humatrope in Pediatric Patients With Genetic Short Stature (SHOX Gene Defect)', 'orgStudyIdInfo': {'id': '2704'}, 'secondaryIdInfos': [{'id': 'B9R-MC-GDFN'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Somatropin (rDNA origin) for injection', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_CHAIR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}}}}