Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT00499993
Status:
COMPLETED
Last Update Posted:
2019-01-15
First Post:
2007-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly
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': 'C060347', 'term': 'lanreotide'}, {'id': 'D000081206', 'term': 'Duration of Therapy'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-11', 'studyFirstSubmitDate': '2007-07-11', 'studyFirstSubmitQcDate': '2007-07-11', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-07-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Growth hormone assessment', 'timeFrame': 'At every visit'}], 'secondaryOutcomes': [{'measure': 'Insulin-like Growth Factor 1 (IGF-1) and Acid-Labile Subunit (ALS) assessments', 'timeFrame': 'At every visit (with the exception of ALS at study inclusion)'}, {'measure': 'Prolactin (PRL) assessment', 'timeFrame': 'At study inclusion, visit 1 and at the final visit of the study'}, {'measure': 'Lanreotide assessment', 'timeFrame': 'At every visit'}, {'measure': 'Clinical symptoms', 'timeFrame': 'At every visit'}, {'measure': 'Quality of life', 'timeFrame': 'At visit 1 and at the final visit of the study'}, {'measure': 'Tumour size', 'timeFrame': 'At inclusion and at the final visit of the study'}, {'measure': 'Evaluation of carotid vessels (on an optional basis)', 'timeFrame': 'At inclusion and at the final visit of the study'}, {'measure': 'Safety assessment evaluated by clinical data', 'timeFrame': 'At every visit'}, {'measure': 'Safety assessment evaluated by laboratory data', 'timeFrame': 'At inclusion visit and at the final visit of the study'}]}, 'conditionsModule': {'conditions': ['Acromegaly']}, 'referencesModule': {'references': [{'pmid': '19542735', 'type': 'RESULT', 'citation': 'Lombardi G, Minuto F, Tamburrano G, Ambrosio MR, Arnaldi G, Arosio M, Chiarini V, Cozzi R, Grottoli S, Mantero F, Bogazzi F, Terzolo M, Tita P, Boscani PF, Colao A. Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in somatostatin analogue-naive patients with acromegaly. J Endocrinol Invest. 2009 Mar;32(3):202-9. doi: 10.1007/BF03346453.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the protocol, is to evaluate if lanreotide Autogel 120 mg is effective in the control of Growth Hormone (GH) secretion in patients with active acromegaly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented diagnosis of active acromegaly, defined by serum GH levels above 5 µg/L, absence of reduction of serum GH levels below 1µg/L after oral glucose tolerance test (OGTT) and abnormal IGF-1 values\n\nExclusion Criteria:\n\n* Patients who have undergone pituitary surgery less than 3 months before selection\n* Patients previously treated with radiotherapy\n* Patients previously treated with somatostatin analogue except for a pre-surgical treatment not longer than 3 months'}, 'identificationModule': {'nctId': 'NCT00499993', 'briefTitle': 'Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'Phase III, Multicentre, Open Clinical Study on the Efficacy and Tolerability of a New Slow-release Formulation of Lanreotide (Autogel 120 mg) in Patients With Active Acromegaly', 'orgStudyIdInfo': {'id': 'A-93-52030-077'}}, 'armsInterventionsModule': {'interventions': [{'name': 'lanreotide (Autogel formulation), duration of treatment 46-48 weeks', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '24128', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Ospedali Riuniti di Bergamo', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '40133', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Ospedale Maggiore', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '25125', 'city': 'Brescia', 'country': 'Italy', 'facility': 'Clinica Medica - Sezione II Medicina Endocrinologia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '09124', 'city': 'Cagliari', 'country': 'Italy', 'facility': 'Università deglis Studi di Cagliari', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'zip': '95123', 'city': 'Catania', 'country': 'Italy', 'facility': 'Ospedale Garibaldi', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '44100', 'city': 'Ferrara', 'country': 'Italy', 'facility': 'Università degli Studi di Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'Università degli Studi di Firenze', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '16100', 'city': 'Genova', 'country': 'Italy', 'facility': 'D.i.S.E.M. Dipartimento di Scienze Endocrinologiche e Metaboliche', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '20100', 'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Auxologico', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale Maggiore IRCCS', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale di Niguarda Cà Granda', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Università "Federico II" di Napoli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '10043', 'city': 'Orbassano (TO)', 'country': 'Italy', 'facility': 'Ospedale "S. Luigi Gonzaga"', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Università degli Studi di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '90148', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Azienda Ospedaliera "V. Cervello"', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '56100', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Ospedale Cisanello', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '42100', 'city': 'Reggio Emilia', 'country': 'Italy', 'facility': 'Servizio di Endocrinologia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'facility': 'Università "La Sapienza" di Roma', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'facility': 'Policlinico Agostino Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '07199', 'city': 'Sassari', 'country': 'Italy', 'facility': 'Istituto di Patologia Speciale Medica e Metodologia Clinica', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}, {'zip': '60020', 'city': 'Sede Di Torrette (AN) Ancona', 'country': 'Italy', 'facility': 'Università degli Studi di Ancona, Ospedale Umberto I'}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'Ospedale Molinette', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '31100', 'city': 'Treviso', 'country': 'Italy', 'facility': 'Ospedale Cà Foncello', 'geoPoint': {'lat': 45.66673, 'lon': 12.2416}}, {'zip': '33100', 'city': 'Udine', 'country': 'Italy', 'facility': 'Ospedale Santa Maria della Misericordia', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}