Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:45 PM
Study NCT ID:
NCT01014793
Status:
COMPLETED
Last Update Posted:
2009-11-17
First Post:
2009-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short and Long Term Efficacy of Combined Cabergoline and Octreotide Treatment in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077465', 'term': 'Cabergoline'}], 'ancestors': [{'id': 'D004873', 'term': 'Ergolines'}, {'id': 'D004876', 'term': 'Ergot Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum for IGI-I, GH and prolactin measures'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-16', 'studyFirstSubmitDate': '2009-11-16', 'studyFirstSubmitQcDate': '2009-11-16', 'lastUpdatePostDateStruct': {'date': '2009-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Control of IGF-I levels', 'timeFrame': 'six months'}], 'secondaryOutcomes': [{'measure': 'control IGI-I levels', 'timeFrame': 'six months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acromegaly resistant', 'combined-treatment', 'dopamine agonist'], 'conditions': ['Acromegaly']}, 'referencesModule': {'references': [{'pmid': '10713101', 'type': 'BACKGROUND', 'citation': 'Rocheville M, Lange DC, Kumar U, Sasi R, Patel RC, Patel YC. Subtypes of the somatostatin receptor assemble as functional homo- and heterodimers. J Biol Chem. 2000 Mar 17;275(11):7862-9. doi: 10.1074/jbc.275.11.7862.'}, {'pmid': '14764779', 'type': 'BACKGROUND', 'citation': 'Holdaway IM, Rajasoorya RC, Gamble GD. Factors influencing mortality in acromegaly. J Clin Endocrinol Metab. 2004 Feb;89(2):667-74. doi: 10.1210/jc.2003-031199.'}, {'pmid': '19208732', 'type': 'BACKGROUND', 'citation': 'Melmed S, Colao A, Barkan A, Molitch M, Grossman AB, Kleinberg D, Clemmons D, Chanson P, Laws E, Schlechte J, Vance ML, Ho K, Giustina A; Acromegaly Consensus Group. Guidelines for acromegaly management: an update. J Clin Endocrinol Metab. 2009 May;94(5):1509-17. doi: 10.1210/jc.2008-2421. Epub 2009 Feb 10.'}, {'pmid': '15272916', 'type': 'RESULT', 'citation': 'Cozzi R, Attanasio R, Lodrini S, Lasio G. Cabergoline addition to depot somatostatin analogues in resistant acromegalic patients: efficacy and lack of predictive value of prolactin status. Clin Endocrinol (Oxf). 2004 Aug;61(2):209-15. doi: 10.1111/j.1365-2265.2004.02082.x.'}, {'pmid': '15817912', 'type': 'RESULT', 'citation': 'Selvarajah D, Webster J, Ross R, Newell-Price J. Effectiveness of adding dopamine agonist therapy to long-acting somatostatin analogues in the management of acromegaly. Eur J Endocrinol. 2005 Apr;152(4):569-74. doi: 10.1530/eje.1.01888.'}, {'pmid': '9467544', 'type': 'RESULT', 'citation': 'Abs R, Verhelst J, Maiter D, Van Acker K, Nobels F, Coolens JL, Mahler C, Beckers A. Cabergoline in the treatment of acromegaly: a study in 64 patients. J Clin Endocrinol Metab. 1998 Feb;83(2):374-8. doi: 10.1210/jcem.83.2.4556.'}, {'pmid': '10753124', 'type': 'RESULT', 'citation': 'Rocheville M, Lange DC, Kumar U, Patel SC, Patel RC, Patel YC. Receptors for dopamine and somatostatin: formation of hetero-oligomers with enhanced functional activity. Science. 2000 Apr 7;288(5463):154-7. doi: 10.1126/science.288.5463.154.'}, {'pmid': '19439914', 'type': 'RESULT', 'citation': 'Jallad RS, Bronstein MD. Optimizing medical therapy of acromegaly: beneficial effects of cabergoline in patients uncontrolled with long-acting release octreotide. Neuroendocrinology. 2009;90(1):82-92. doi: 10.1159/000218323. Epub 2009 May 8.'}, {'pmid': '16181243', 'type': 'RESULT', 'citation': 'Gatta B, Hau DH, Catargi B, Roger P, Tabarin A. Re-evaluation of the efficacy of the association of cabergoline to somatostatin analogues in acromegalic patients. Clin Endocrinol (Oxf). 2005 Oct;63(4):477-8. doi: 10.1111/j.1365-2265.2005.02329.x. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'In acromegaly, nearly 40% of patients fail to control GH/IGF-I levels with somatostatin analogues (SA). Dopaminergic agonists (DA) are even less effective, but combination therapy with SA and DA normalizes IGF-I levels in 33-56% of patients in short-term studies. This study was designed to evaluate short and long term efficacy of cabergoline in controlling IGF-I levels in acromegalic patients receiving octreotide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Nineteen acromegalic patients (Neuroendocrine Unit-UNIFESP)with active disease, resistant to octreotide were enrolled', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active disease, under octreotide treatment at least 9 months\n\nExclusion Criteria:\n\n* Cabergoline allergy'}, 'identificationModule': {'nctId': 'NCT01014793', 'briefTitle': 'Short and Long Term Efficacy of Combined Cabergoline and Octreotide Treatment in Acromegalic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Short and Long Term Efficacy of Combined Treatment in Controlling IGI-I Levels in Acromegaly', 'orgStudyIdInfo': {'id': 'Mattapr1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Responders to cabergoline', 'description': 'patients with active disease under octreotide treatment received addition of increasing doses of cabergoline (1.0, 2.0 and 3.5mg/week)', 'interventionNames': ['Drug: cabergoline']}], 'interventions': [{'name': 'cabergoline', 'type': 'DRUG', 'otherNames': ['cabergoline-Dostinex'], 'description': 'cabergoline doses were increased at 6-week intervals, starting at 1.0mg/week followed by 2.0 and 3.5mg/week. Hormonal evaluations (IGF-I, GH and PRL) started before the first dose and were repeated at 6-week intervals after each cabergoline dose and after cabergoline withdrawal', 'armGroupLabels': ['Responders to cabergoline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04039030', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Federal University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Julio Abucham, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Federal University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Priscilla Olim de Andrade MAttar', 'oldOrganization': 'Federal University of Sao Paulo'}}}}