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Sponsored by: |
Wyeth |
Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00243295 |
To assess the feasibility of using rhBMP-2/CPM in OWO as a surgical model for pharmacodynamic studies, with assessment of the following parameters:
Condition | Intervention | Phase |
Osteoarthritis |
Drug: rhBMP-2/CPM |
Phase I |
MedlinePlus related topics: | Osteoarthritis |
ChemIDplus related topics: | Calcium gluconate Calcium phosphate Dibotermin alfa |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study |
Official Title: | 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 |
Estimated Enrollment: | 6 |
Study Start Date: | November 2003 |
Estimated Study Completion Date: | March 2005 |
Ages Eligible for Study: | 45 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Other inclusion applies.
Exclusion Criteria:
Other exclusion applies.
Study ID Numbers: | 3100N7-110 |
First Received: | October 19, 2005 |
Last Updated: | October 5, 2006 |
ClinicalTrials.gov Identifier: | NCT00243295 |
Health Authority: | France: Ministry of Health |
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