Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-22 @ 7:26 AM
Study NCT ID:
NCT00514657
Status:
COMPLETED
Last Update Posted:
2007-08-10
First Post:
2007-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C114444', 'term': 'trafermin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-08-09', 'studyFirstSubmitDate': '2007-08-09', 'studyFirstSubmitQcDate': '2007-08-09', 'lastUpdatePostDateStruct': {'date': '2007-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of increase in alveolar bone height', 'timeFrame': '36 weeks after administration'}, {'measure': 'clinical attachment level (CAL) regained', 'timeFrame': '36 weeks after administration'}], 'secondaryOutcomes': [{'measure': 'time course of rate of increase in alveolar bone height', 'timeFrame': 'within 36 weeks after administration'}, {'measure': 'time course of CAL regained', 'timeFrame': 'within 36 weeks after administration'}, {'measure': 'the other periodontal inspections (PD, BOP, GI etc.)', 'timeFrame': 'within 36 weeks after administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Periodontitis']}, 'referencesModule': {'references': [{'pmid': '18596969', 'type': 'DERIVED', 'citation': 'Kitamura M, Nakashima K, Kowashi Y, Fujii T, Shimauchi H, Sasano T, Furuuchi T, Fukuda M, Noguchi T, Shibutani T, Iwayama Y, Takashiba S, Kurihara H, Ninomiya M, Kido J, Nagata T, Hamachi T, Maeda K, Hara Y, Izumi Y, Hirofuji T, Imai E, Omae M, Watanuki M, Murakami S. Periodontal tissue regeneration using fibroblast growth factor-2: randomized controlled phase II clinical trial. PLoS One. 2008 Jul 2;3(7):e2611. doi: 10.1371/journal.pone.0002611.'}]}, 'descriptionModule': {'briefSummary': 'The present clinical trial clarified that basic fibroblast growth factor-2 (FGF-2) can induce regeneration of periodontal tissue lost by progression of periodontitis and evaluated the safety of such induction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed as 2- or 3-walled vertical intrabony defect \\>=3 mm deep from the top of the remaining alveolar bone\n* with mobility of the tooth of degree 2 or less\n* with width of attached gingiva appropriate for Guided Tissue Regeneration\n\nExclusion Criteria:\n\n* concomitant administration of adrenal cortical steroid within 4 wks after the surgery\n* administeration of calcium antagonist during the 4 weeks preceding administration of the investigational drug\n* coexisting malignant tumour or history of the same\n* coexisting diabetes (HbA1C \\>= 6.5%)\n* an extremely poor nutritional condition (serum albumin concentration \\<2 g/dL)\n* pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT00514657', 'briefTitle': 'Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kaken Pharmaceutical'}, 'officialTitle': 'Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2 (Randomised Controlled Phase II Clinical Trial)', 'orgStudyIdInfo': {'id': 'KCB-1D-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'P', 'interventionNames': ['Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)']}, {'type': 'EXPERIMENTAL', 'label': 'L', 'description': 'low dose (0.03 %)', 'interventionNames': ['Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)']}, {'type': 'EXPERIMENTAL', 'label': 'M', 'description': 'medium dose (0.1 %)', 'interventionNames': ['Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)']}, {'type': 'EXPERIMENTAL', 'label': 'H', 'description': 'high dose (0.3 %)', 'interventionNames': ['Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)']}], 'interventions': [{'name': 'Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)', 'type': 'DRUG', 'armGroupLabels': ['H', 'L', 'M', 'P']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Makoto Tamura, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kaken Pharmaceutical Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaken Pharmaceutical', 'class': 'INDUSTRY'}}}}