Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:40 AM
Study NCT ID:
NCT00055302
Status:
COMPLETED
Last Update Posted:
2015-09-01
First Post:
2003-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Arimidex in McCune Albright Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Spain', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005359', 'term': 'Fibrous Dysplasia, Polyostotic'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D005357', 'term': 'Fibrous Dysplasia of Bone'}], 'ancestors': [{'id': 'D010009', 'term': 'Osteochondrodysplasias'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077384', 'term': 'Anastrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-31', 'studyFirstSubmitDate': '2003-02-25', 'studyFirstSubmitQcDate': '2003-02-25', 'lastUpdatePostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy of study treatment will be assessed based on the change from baseline measurements relating to vaginal bleeding, bone age, and growth velocity', 'timeFrame': '12 months or until the subject demonstrates the lack of efficacy bases upon progression of primary endpoints or experiences serious drug-related toxicity requiring withdrawal'}]}, 'conditionsModule': {'keywords': ['vaginal bleeding', 'advanced bone age', 'fibrous dysplasia', 'MAS', 'McCune-Albright Syndrome'], 'conditions': ['McCune-Albright Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1503&filename=CSR-1033IL-0046.pdf', 'label': 'CSR-1033IL-0046.pdf'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the safety and efficacy of anastrozole 1 mg given once daily in subjects with McCune-Albright Syndrome.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed written consent of parent/legal guardian and subject assent (as needed by local requirements)\n* females less than or equal to 10 years of age\n* diagnosed with McCune-Albright Syndrome\n* have progressive precocious puberty\n\nExclusion Criteria: Any one of the following is regarded as a criterion for exclusion from the study:\n\n* any prior treatment of MAS associated with progressive precocious puberty with a third generation aromatase inhibitor (anastrozole, letrozole, exemestane) in which no clinical response was seen\n* concomitant treatment of precocious puberty associated with MAS, with the exception of bisphosphonates for polyostotic fibrous dysplasia and LHRH analogues in the case of central precocious puberty\n* liver function tests at screening visit (AST, ALT) \\> or = 3x the upper limit of the reference range for age\n* known hypersensitivity to any component of study medication'}, 'identificationModule': {'nctId': 'NCT00055302', 'briefTitle': 'Arimidex in McCune Albright Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open-label Study Evaluating the Safety and Efficacy of Anastrozole™ (ARIMIDEX) in the Treatment of Precocious Puberty in Girls With McCune-Albright Syndrome', 'orgStudyIdInfo': {'id': '1033IL/0046'}, 'secondaryIdInfos': [{'id': 'D5394C00046'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Arimidex 1 mg']}], 'interventions': [{'name': 'Arimidex 1 mg', 'type': 'DRUG', 'description': 'Arimidex (anastrozole) 1mg once daily by mouth', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montpellier', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Paris', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Erlangen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'city': 'Osnabrück', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'AstraZeneca Arimidex Medical Science Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}