Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-20 @ 12:39 PM
Study NCT ID:
NCT00616551
Status:
COMPLETED
Last Update Posted:
2008-10-08
First Post:
2008-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of C2L-OCT-01 PR in Acromegalic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Serbia and Montenegro']}, '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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-07', 'studyFirstSubmitDate': '2008-02-04', 'studyFirstSubmitQcDate': '2008-02-04', 'lastUpdatePostDateStruct': {'date': '2008-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the mean serum concentrations of insulin-like growth factor-1 (IGF-1) and growth hormone (GH) in patients treated with C2L-OCT-01 PR, 30 mg or Sandostatin LAR 30 mg', 'timeFrame': 'Days 1, 28, 42, 56 and 84'}], 'secondaryOutcomes': [{'measure': 'Compare plasma concentrations, efficacy and safety profile of C2L-OCT-01 PR', 'timeFrame': '84 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acromegaly'], 'conditions': ['Acromegaly']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the biological safety and efficacy of using the drug, C2L-OCT-01 PR, 30 mg to treat acromegalic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be diagnosed with active acromegaly.\n* If subject is treated with a long acting somatostatin analogue, the treatment must have been unchanged for a period of at least 12 weeks prior to entry.\n* If subject is treated with a 30 mg dose of a depot formulation of a somatostatin analogue, the IGF-1 levels must be normal at entry.\n* If subject is treated with a 20 mg dose of a depot formulation of a somatostatin analogue, any value of IGF-1 is acceptable.\n* If the subject is receiving an immediate release formulation of a somatostatin analogue or a dopamine agonist, the IGF-1 values must be above 10% of the reference range based on gender and age.\n* If the subject is receiving a dopamine agonist, it must be stopped 14 days prior to receiving the study medication.\n* The subject should be able to understand the instructions, provide a written consent and abide by the study restrictions.\n\nExclusion Criteria:\n\n* Women of childbearing potential who are not taking adequate contraception or who are pregnant or lactating.\n* Subjects previously treated with a growth hormone receptor antagonist (Pegvisomant) within 12 weeks of study entry.\n* Subjects who have undergone pituitary surgery within 6 months or radiotherapy within 2 years prior to admission into the study\n* Subjects who present some form of intolerance or allergy to the test article or one of its non-active ingredients\n* Subject who have any other condition that alters the growth hormone or IGF-1 levels.\n* Subjects with signs or symptoms related to a tumor compression of the optical chiasm.'}, 'identificationModule': {'nctId': 'NCT00616551', 'briefTitle': 'Efficacy and Safety of C2L-OCT-01 PR in Acromegalic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ambrilia Biopharma, Inc.'}, 'officialTitle': 'Open Label, Randomized Study Comparing the Biological Efficacy & Safety of a New Prolonged Release Formulation of Octreotide Acetate, C2L-OCT-01 PR, 30 mg Administered Every 42 Days for 84 Days With Sandostatin LAR 30 mg Administered Every 28 Days for 84 Days to Acromegalic Patients', 'orgStudyIdInfo': {'id': 'C2L-OCT-01 PR-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: C2L-OCT-01 PR, 30 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: Octreotide acetate prolonged release, 30 mg']}], 'interventions': [{'name': 'C2L-OCT-01 PR, 30 mg', 'type': 'DRUG', 'description': 'Administered by deep IM injection (gluteus) on days 1 and 42', 'armGroupLabels': ['A']}, {'name': 'Octreotide acetate prolonged release, 30 mg', 'type': 'DRUG', 'otherNames': ['Sandostatin LAR, 30 mg'], 'description': 'Administered by deep IM (gluteus) on Days 1, 28 and 56', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Minsk', 'country': 'Belarus', 'facility': 'Republican Centre for Medical Rehabilitation and Water-therapy', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis Egyetem Általános Orvostudományi', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Institute of Endocrinology "C. I. Parhon" Bucharest', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Institute of Endocrinology, University Clinical Center', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Fakultná Nemocnica s Poliklinkou Bratislava', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'city': 'Kiev', 'country': 'Ukraine', 'facility': 'V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}], 'overallOfficials': [{'name': 'Raphael Naudin, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ambrilia Biopharma, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ambrilia Biopharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Bonabes de Rouge, M.D./Senior Executive Vice-President & Chief Scientist Officer', 'oldOrganization': 'Ambrilia Biopharma, Inc.'}}}}