Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-18 @ 6:49 PM
Study NCT ID:
NCT01015404
Status:
COMPLETED
Last Update Posted:
2013-10-21
First Post:
2009-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2013-10-17', 'studyFirstSubmitDate': '2009-11-16', 'studyFirstSubmitQcDate': '2009-11-16', 'lastUpdatePostDateStruct': {'date': '2013-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum Trafermin level', 'timeFrame': 'within 4 weeks'}], 'secondaryOutcomes': [{'measure': 'occurrence and level of adverse reaction', 'timeFrame': 'within 4 weeks'}, {'measure': 'serum anti-Trafermin antibody level', 'timeFrame': 'within 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Trafermin', 'Periodontitis'], 'conditions': ['Periodontitis']}, 'referencesModule': {'references': [{'pmid': '18596969', 'type': 'RESULT', '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': 'This study aims to investigate the safety in using Trafermin (recombinant human basic fibroblast growth factor) with periodontal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vertical intrabony defect from radiographs at baseline\n* Age of 20 years or older\n\nExclusion Criteria:\n\n* Using an investigational drug within the past 24 months\n* Coexisting malignant tumour or history of the same\n* Coexisting diabetes (HbA1C 6.5% or more)\n* Taking bisphosphonates\n* Coexisting gingival overgrowth or history of the same'}, 'identificationModule': {'nctId': 'NCT01015404', 'briefTitle': 'A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kaken Pharmaceutical'}, 'officialTitle': 'A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)', 'orgStudyIdInfo': {'id': 'KCB-1D-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental H', 'description': 'high volume (0.6mL、0.3% Trafermin)', 'interventionNames': ['Drug: Trafermin']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental L', 'description': 'low volume (0.2mL、0.3% Trafermin)', 'interventionNames': ['Drug: Trafermin']}], 'interventions': [{'name': 'Trafermin', 'type': 'DRUG', 'otherNames': ['KCB-1D'], 'description': 'Administered to the bone defect during flap operation', 'armGroupLabels': ['Experimental H', 'Experimental L']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chiyoda-ku', 'country': 'Japan', 'facility': 'Kaken Investigational Site 5'}, {'city': 'Matsudo', 'country': 'Japan', 'facility': 'Kaken Investigational Site 2', 'geoPoint': {'lat': 35.77995, 'lon': 139.90144}}, {'city': 'Ōta-ku', 'country': 'Japan', 'facility': 'Kaken Investigational Site 3', 'geoPoint': {'lat': 35.56126, 'lon': 139.71605}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': 'Kaken Investigational Site 1', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Shinjuku-ku', 'country': 'Japan', 'facility': 'Kaken Investigational Site 4'}, {'city': 'Suita', 'country': 'Japan', 'facility': 'Kaken Investigational Site 6', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}], 'overallOfficials': [{'name': 'Chikara Ieda', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kaken Pharmaceutical Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaken Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}