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| Descriptive Information Fields | |||||||||
| Brief Title † | Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures | ||||||||
| Official Title † | A Phase 1 Dose-Escalating, Double-Blind, Placebo-Controlled, Multicenter, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy for Closed Distal Radius Fractures | ||||||||
| Brief Summary | To evaluate the safety of rhBMP-2/CPM administered to subjects presenting with closed distal radius fractures. The key safety variables comprising this assessment are: 1) incidence of delayed union; 2) median time to fracture union (assessed by the investigators); 3) incidence of local neurovascular events (those involving the region under study [RUS]); and 4) rate of fracture displacement. The primary objective will be met if these outcomes in the active and placebo treatment groups are at least comparable to those of the SOC control group. |
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| Detailed Description | |||||||||
| Study Phase | Phase I | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study | ||||||||
| Primary Outcome Measure † | Determine the safety of administering rhBMP-2/CPM to subjects with distal radius fractures that require surgical fixation. | ||||||||
| Secondary Outcome Measure † | Feasibility of the test article injection procedure and localization of the test article relative to the distal radius fracture site. | ||||||||
| Condition † | Radius Fractures | ||||||||
| Intervention † | Drug: rhBMP-2/CPM | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 40 | ||||||||
| Start Date † | September 2005 | ||||||||
| Completion Date | January 2007 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Other inclusion applies. Exclusion Criteria:
Other exclusion applies. |
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| Gender | Both | ||||||||
| Ages | 50 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | Finland, France | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00161629 | ||||||||
| Organization ID | 3100N7-114 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Wyeth | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Wyeth | ||||||||
| Verification Date | December 2007 | ||||||||
| First Received Date † | September 1, 2005 | ||||||||
| Last Updated Date | December 3, 2007 | ||||||||