Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-14 @ 8:38 AM
Study NCT ID:
NCT02807233
Status:
COMPLETED
Last Update Posted:
2019-08-05
First Post:
2016-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) in Acromegalic Subjects
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-01', 'studyFirstSubmitDate': '2016-05-27', 'studyFirstSubmitQcDate': '2016-06-16', 'lastUpdatePostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects with a normal Insulin-like Growth Factor 1 (IGF-1) level in the assay before the study visit.', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'Percentage of subjects with Growth hormone (GH) levels ≤ 2.5 ng/mL or ≤ 1 ng/mL in the assay before the study visit.', 'timeFrame': 'Day 1'}, {'measure': 'Percentage of subjects treated with lanreotide autogel (ATG) 120 mg for ≥ 6 months with dosing intervals of five, six, seven or eight weeks.', 'timeFrame': 'Day 1'}, {'measure': 'Percentage of subjects whose dosing regimen has been changed in the six months before the study.', 'timeFrame': 'Day 1'}, {'measure': 'Preference for self-administered injections or administration in an outpatient clinic by a medical professional.', 'timeFrame': 'Day 1'}, {'measure': 'Acromegaly Quality of Life Questionnaire (AcroQoL) in subjects after ≥ 5 months of treatment with ATG 120 mg at extended dosing intervals.', 'timeFrame': 'Day 1', 'description': 'Total score and score per domain'}, {'measure': 'EuroQol-5D (EQ-5D) questionnaire in subjects after ≥ 5 months of treatment with ATG 120 mg at extended dosing intervals.', 'timeFrame': 'Day 1', 'description': 'Total score and score per domain'}, {'measure': 'Treatment Satisfaction Questionnaire for Medication-9 (TSMQ-9) in subjects treated with ATG 120 mg at extended dosing intervals after ≥ 5 months.', 'timeFrame': 'Day 1', 'description': 'Total score and score per domain'}, {'measure': 'Variations between theoretical and real treatment compliance for non-medical reasons.', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acromegaly']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness in IGF-1 control of lanreotide Autogel (ATG) 120 mg at extended dosing intervals (EDIs) (\\>4 weeks) in subjects with acromegaly in daily clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospital patients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men or women aged ≥ 18 years\n* Diagnosed with acromegaly\n* Receiving treatment with ATG 120 mg at extended dosing intervals (\\> 4 weeks) for at least six months before the study visit.\n* Assay data (blood GH and IGF-1 levels) from immediately before the study visit (performed at least six months after starting the treatment) is available.\n* Able to sign the informed consent form for study participation.\n\nExclusion Criteria:\n\n* Received radiation therapy treatment in the last six months.\n* Active participation in another clinical study.\n* Physical or mental disorders that, in the investigator's opinion, could affect their ability to sign the informed consent form.\n* Pregnancy or breastfeeding for female patients.\n* No data in their medical records on the treatment start date for ATG 120 mg at extended dosing intervals or on changes to the schedule of administration over the last six months."}, 'identificationModule': {'nctId': 'NCT02807233', 'acronym': 'SOMACROL', 'briefTitle': 'Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) in Acromegalic Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'Observational, Multicenter, Cross-sectional, Observational Study to Evaluate the Effectiveness in Routine Clinical Practice of Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) for the Treatment of Acromegaly: SOMACROL Study.', 'orgStudyIdInfo': {'id': 'A-ES-52030-352'}, 'secondaryIdInfos': [{'id': 'IPS-SOM-2015-01', 'type': 'OTHER', 'domain': 'Spanish Drug Agency AEMPS'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1649-035', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital de Santa Maria', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4200-319', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Centro Hospitalar Sao Jöao', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '38010', 'city': 'Santa Cruz', 'state': 'Tenerife', 'country': 'Spain', 'facility': 'Hospital Univ. Nuestra Sra. Candelaria', 'geoPoint': {'lat': 38.0218, 'lon': -1.05749}}, {'zip': '15006', 'city': 'A Coruña', 'country': 'Spain', 'facility': 'Complejo Hospitalario Univ. A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '28805', 'city': 'Alcalá de Henares', 'country': 'Spain', 'facility': 'Hospital Univ. Príncipe de Asturias', 'geoPoint': {'lat': 40.48205, 'lon': -3.35996}}, {'zip': '03010', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General Univ. de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '46600', 'city': 'Alzira', 'country': 'Spain', 'facility': 'Hospital Univ. La Ribera', 'geoPoint': {'lat': 39.15, 'lon': -0.43333}}, {'zip': '06006', 'city': 'Badajoz', 'country': 'Spain', 'facility': 'Hospital Infanta Cristina', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'zip': '48903', 'city': 'Barakaldo', 'country': 'Spain', 'facility': 'Hospital Cruces', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'zip': '11009', 'city': 'Cadiz', 'country': 'Spain', 'facility': 'Hospital Puerta del Mar', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'zip': '13005', 'city': 'Ciudad Real', 'country': 'Spain', 'facility': 'Hospital Ciudad Real', 'geoPoint': {'lat': 38.98626, 'lon': -3.92907}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Hospital Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '28905', 'city': 'Getafe', 'country': 'Spain', 'facility': 'Hospital de Getafe', 'geoPoint': {'lat': 40.30571, 'lon': -3.73295}}, {'zip': '17007', 'city': 'Girona', 'country': 'Spain', 'facility': 'Hospital Univ. Girona Dr. Josep Trueta', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'zip': '23005', 'city': 'Jaén', 'country': 'Spain', 'facility': 'Hospital de Jaén', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'country': 'Spain', 'facility': 'Hospital Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '24001', 'city': 'León', 'country': 'Spain', 'facility': 'Hospital Univ. León', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'zip': '25198', 'city': 'Lleida', 'country': 'Spain', 'facility': 'Hospital Arnau de Vilanova', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Univv. La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28222', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Puerta del Hierro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29009', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Civil de Málaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '33011', 'city': 'Oviedo', 'country': 'Spain', 'facility': 'Hospital Univ. Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '07120', 'city': 'Palma', 'country': 'Spain', 'facility': 'Hospital Univ. Son Espases', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '08208', 'city': 'Sabadell', 'country': 'Spain', 'facility': 'Corporacio Sanitaria Parc Tauli', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '28702', 'city': 'San Sebastián de los Reyes', 'country': 'Spain', 'facility': 'Hospital Infanta Sofía', 'geoPoint': {'lat': 40.55555, 'lon': -3.62733}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'Hospital Clínico Univ. Santiago', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '08221', 'city': 'Terrassa', 'country': 'Spain', 'facility': 'Hospital Univ. Alava', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '08221', 'city': 'Terrassa', 'country': 'Spain', 'facility': 'Hospital Univ. Mutua de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '44002', 'city': 'Teruel', 'country': 'Spain', 'facility': 'Hospital Obispo Polanco', 'geoPoint': {'lat': 40.3456, 'lon': -1.10646}}, {'zip': '45005', 'city': 'Toledo', 'country': 'Spain', 'facility': 'Hospital Virgen de la Salud', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Univ. La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '47003', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Clínico Univ. Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}