Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2026-01-03 @ 10:20 PM
Study NCT ID:
NCT00128232
Status:
COMPLETED
Last Update Posted:
2012-04-30
First Post:
2005-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000172', 'term': 'Acromegaly'}], 'ancestors': [{'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006964', 'term': 'Hyperpituitarism'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'lastUpdateSubmitDate': '2012-04-27', 'studyFirstSubmitDate': '2005-08-08', 'studyFirstSubmitQcDate': '2005-08-08', 'lastUpdatePostDateStruct': {'date': '2012-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean GH and IGF-I at baseline, week 12, 24 and 48'}], 'secondaryOutcomes': [{'measure': 'Tumor volume at baseline, week 24 and 48'}, {'measure': 'Signs and symptoms of acromegaly at baseline, week 12, 24 and 48'}, {'measure': 'Safety and tolerability at any time on treatment'}]}, 'conditionsModule': {'keywords': ['Acromegaly', 'untreated', 'newly diagnosed', 'octreotide LAR'], 'conditions': ['Acromegaly']}, 'descriptionModule': {'briefSummary': 'Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. Octreotide LAR is approved for treatment of acromegaly after surgery if the disease is not controlled. This study was aimed to test the safety and efficacy of octreotide LAR in acromegalic patients who did not have any previous treatment for acromegaly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed or previously untreated acromegalic patients\n* Lack of suppression of growth hormone (GH) nadir to \\<1.0 µg/L, after oral administration of 75g of glucose (oral glucose tolerance test \\[OGTT\\])\n* Insulin-like growth factor-I (IGF-I) levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender)\n\nExclusion Criteria:\n\n* Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass\n* No evidence of pituitary adenoma on magnetic resonance imaging (MRI)\n* Symptomatic cholelithiasis'}, 'identificationModule': {'nctId': 'NCT00128232', 'briefTitle': 'Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Safety and Efficacy of Octreotide LAR in Treatment Naïve Acromegalic Patients', 'orgStudyIdInfo': {'id': 'CSMS995B2401'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Octreotide LAR', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Stephan Petersenn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universität Duisburg-Essen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}