Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00161629
Study type	Interventional
Source	Wyeth is now a wholly owned subsidiary of Pfizer
Contact
Status	Completed
Phase	Phase 1
Start date	September 2005
Completion date	January 2007

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