Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-03 @ 3:11 AM
Study NCT ID:
NCT00243295
Status:
COMPLETED
Last Update Posted:
2006-10-06
First Post:
2005-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'ECT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-10', 'completionDateStruct': {'date': '2005-03'}, 'lastUpdateSubmitDate': '2006-10-05', 'studyFirstSubmitDate': '2005-10-19', 'studyFirstSubmitQcDate': '2005-10-19', 'lastUpdatePostDateStruct': {'date': '2006-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of injecting rhBMP-2/CPM using high tibial osteotomy as a surgical model for pharmacodynamic studies'}, {'measure': 'Feasibility measures include'}, {'measure': 'Injection of desired volume of rhBMP-2/CPM within the osteotomy defect'}, {'measure': 'Ability to perform longitudinal radiographic absorptiometry of the defect in the presence of rhBMP-2/CPM.'}], 'secondaryOutcomes': [{'measure': 'Safety of administering different volumes of rhBMP-2/CPM in high tibial osteotomy defects. Safety assessed by evaluation of adverse events reported during the duration of the trial.'}]}, 'conditionsModule': {'keywords': ['osteoarthritis', 'deformity of knee'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'To assess the feasibility of using rhBMP-2/CPM in OWO as a surgical model for pharmacodynamic studies, with assessment of the following parameters:\n\n* Injecting the desired volume of rhBMP-2/CPM within the defect\n* Conducting longitudinal radiographic absorptiometry of the tibial defect in the presence of rhBMP-2/CPM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects 45 to 70 years of age\n* Within 96 hours prior to dosing, the subject underwent a successful open wedge tibial osteotomy to correct medial compartment OA of the knee.\n* Female subjects of childbearing potential must have a negative pregnancy test (hospital acceptable test), upon hospitalization for OWO and agree to use medically approved contraception for the duration of the study.\n\nOther inclusion applies.\n\nExclusion Criteria:\n\n* Subjects with pre-existing conditions of the knee or tibia that would confound an interpretation of results.\n* Subjects for whom surgery in the opposite knee is planned during the 6 months of follow-up.\n* Subjects with a history of malignancy or radiotherapy or chemotherapy for malignancy within the past 5 years, except subjects with a history of basal skin carcinoma.\n\nOther exclusion applies.'}, 'identificationModule': {'nctId': 'NCT00243295', 'briefTitle': 'Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Pilot Study to Validate the Feasibility of Injecting and Monitoring Recombinant Human Bone Morphogenetic Protein-2/Calcium Phosphate Matrix (rhBMP-2/CPM) in Subjects With Open Wedge Osteotomies', 'orgStudyIdInfo': {'id': '3100N7-110'}}, 'armsInterventionsModule': {'interventions': [{'name': 'rhBMP-2/CPM', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}}}}