Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:35 PM
Study NCT ID:
NCT00210457
Status:
COMPLETED
Last Update Posted:
2020-03-31
First Post:
2005-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) 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': 'C060347', 'term': 'lanreotide'}]}}, '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': '2000-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2002-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2005-09-19', 'studyFirstSubmitQcDate': '2005-09-19', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients having a normal (age-adjusted) serum insulin-like growth factor 1 (IGF-1) level at end point (Week 48)'}], 'secondaryOutcomes': [{'measure': 'Percentage of variation from baseline of the IGF-1 levels expressed as a percentage of the upper limit of the age-adjusted normal range'}, {'measure': 'Mean growth hormone (GH) levels'}, {'measure': 'Number of patients having a serum GH level at or below 2.5ng/ml'}, {'measure': 'Number of patients having a serum GH level at or below 1 ng/ml'}, {'measure': 'Number of patients with no or reduced clinical signs of acromegaly'}, {'measure': 'Long-term safety of repeated injections of lanreotide autogel at titrated doses'}]}, 'conditionsModule': {'conditions': ['Acromegaly']}, 'referencesModule': {'references': [{'pmid': '18248639', 'type': 'RESULT', 'citation': 'Chanson P, Borson-Chazot F, Kuhn JM, Blumberg J, Maisonobe P, Delemer B; Lanreotide Acromegaly Study Group. Control of IGF-I levels with titrated dosing of lanreotide Autogel over 48 weeks in patients with acromegaly. Clin Endocrinol (Oxf). 2008 Aug;69(2):299-305. doi: 10.1111/j.1365-2265.2008.03208.x. Epub 2008 Jan 31.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel given in doses titrated to effect in acromegalic patients previously treated or not with somatostatin analogues.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient having documentation supporting diagnosis of active acromegaly in one of the following definitions:\n\n * patient having received neither somatostatin analogue nor dopaminergic agonist within the previous 12 weeks and having an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range,\n * patient being treated with a somatostatin analogue (other than lanreotide autogel) or a dopaminergic agonist when attending the first visit and having at the end of the wash-out period an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range.\n\nExclusion Criteria:\n\n* Patient having had pituitary surgery within the previous 3 months\n* Patient having received radiotherapy for acromegaly disease within the previous 36 months\n* Patient being predicted to require pituitary surgery (adenomectomy) or receive radiotherapy during the study period\n* Patient having received lanreotide autogel at any time before the study'}, 'identificationModule': {'nctId': 'NCT00210457', 'briefTitle': 'Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'Phase III, Multicentre, Open Study to Assess the Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Previously Treated or Not by Somatostatin Analogues.', 'orgStudyIdInfo': {'id': 'E-54-52030-081'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lanreotide (Autogel formulation)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'Hôpital Sud', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49033', 'city': 'Angers', 'country': 'France', 'facility': "Chu d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '76233', 'city': 'Bois-Guillaume', 'country': 'France', 'facility': 'Hôpital de Bois Guillaume', 'geoPoint': {'lat': 49.4602, 'lon': 1.12219}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'Chu de la Cote de Nacre', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '21034', 'city': 'Dijon', 'country': 'France', 'facility': 'Hôpital du Bocage', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Chu de Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Hôpital du Cluzeau', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69394', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Neurologique', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '34059', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital Lapeyronie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': "Hôpital de l'Archet 1", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Hôpital du Haut-Levêque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Hôpital Maison Blanche', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35056', 'city': 'Rennes', 'country': 'France', 'facility': 'Hôpital Sud', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Hôpital Bellevue', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hôpital de Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31403', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital de Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': 'CH-1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}