Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161629
Status:
COMPLETED
Last Update Posted:
2007-12-05
First Post:
2005-09-01
Brief Title:
Study Evaluating rhBMP-2CPM in Closed Distal Radius Fractures
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Phase 1 Dose-Escalating Double-Blind Placebo-Controlled Multicenter Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 rhBMP-2Calcium Phosphate Matrix CPM as an Adjuvant Therapy for Closed Distal Radius Fractures
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety of rhBMP-2CPM 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None